china reform of the regulatory environment
TRANSCRIPT
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China
Reform of the
Regulatory
Environment
Author Name Lei Zhu Author Title Global Regulatory Consulting
Date Sep 2020
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Contents
Abbreviations .............................................................................................................................................. 12
Background ................................................................................................................................................. 13
Reform Impacts: 2016 ................................................................................................................................. 15
Self-inspection of clinical data ................................................................................................................. 15
Priority review .......................................................................................................................................... 16
Additional capacity at CDE ...................................................................................................................... 17
Marketing Authorisation Holder rationalisation / new classification /definition of new drugs .................. 18
Generic drug quality and efficacy consistency Evaluation (GQCE) ........................................................ 18
Reform Impacts: 2017 ................................................................................................................................. 19
Opening up of first-in-human (FIH) Phase I trials to global development ............................................... 20
Simplified process for gaining a marketing approval ............................................................................... 20
Clinical trial management 11..................................................................................................................... 20
Acceleration of drug and medical device registration review process11 .................................................. 22
Drug and medical device lifecycle management11 .................................................................................. 23
Protecting innovator’s rights11 ................................................................................................................. 23
Reform Impacts: 2018 ................................................................................................................................. 25
NHC release the Rare Disease List ........................................................................................................ 25
NMPA was elected as a member of the ICH Management Committee .................................................. 25
Announcement of NMPA on Technical Guideline for Acceptance of Overseas Drug Clinical Trial Data
(2018, No.52) ........................................................................................................................................... 25
NMPA released the Circular on Adjusting the Approval Process for Drug Clinical Trial Evaluation (2018,
Circular 50) .............................................................................................................................................. 26
NPC decided that the three-year period for the MAH pilot project is extended by one year .................. 26
Accelerate approval of urgently needed overseas new drugs ................................................................ 27
Legislate independent Vaccine Administration Law17 ............................................................................. 27
CDE website add functions of IND permission ....................................................................................... 28
Reform Impacts: 2019 ................................................................................................................................. 29
Status of qualification notification of clinical site for medical device now available19 .............................. 29
MAH ADR direct reporting system online ................................................................................................ 29
High level decision on State Council executive meeting for oncology and rare disease drugs20 ........... 29
China to establish collaboration network for rare disease diagnosis, treatment21 .................................. 30
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2018 CDE Performance Review Meeting22 ............................................................................................. 30
Drug volume purchasing pilot scheme in 4 (municipality cities)+7 (big cities)23 ..................................... 31
2019 Report on the work of the government24 ........................................................................................ 31
eCTD implementation progress and plan in China ................................................................................. 33
Medical Device Animal Study Technical Review Guideline Part I: Decision Principles25 ....................... 33
Medical device online registration system starts in Jun 201926 ............................................................... 34
Approval procedure of medical device clinical trial permit application changed to implied approval27 ... 34
Second batch of clinical urgently needs oversea new drugs 28 ............................................................... 35
NMPA advancing regulatory science initiatives in drug and medical device in China29 ......................... 35
State Council releases legislative work plan for 201930 .......................................................................... 35
CDE solicit public comments on Key Considerations in Using Real World Evidence to Support Drug
Development31 ......................................................................................................................................... 36
NHC solicited public comments on third batch of encouraging drug list for pediatric32 .......................... 36
State Council issued the human genetic resources management regulations33 ..................................... 36
NMPA published the Medical Device registration 2018 annual review34 ................................................ 37
Jiao Hong attended the first BBS conference on global health in boao Asia35 ....................................... 37
CDE published the Drug registration 2018 annual review36 .................................................................... 37
Vaccine Administration Law approved by the Standing Committee of the Chinese People's Congress37
................................................................................................................................................................. 38
NMPA Improvement Policy Concerning Bundling Review and Approval for Drugs and the
Corresponding Supervision Plan38 .......................................................................................................... 38
State Council high level opinion on building a professional and specialized team of pharmaceutical
products inspection39 ............................................................................................................................... 38
Q&A on R&D of Biosimilars40 .................................................................................................................. 39
Revision of the Drug Administration Law of the People's Republic of China 41 ...................................... 40
NHSA Publishes Drug Catalogue of the National Basic Medical Insurance, Industry Injury Insurance
and Maternity Insurance42 ....................................................................................................................... 41
Implementation Plan to Support the Development of Boao International Medical Tourism Pilot Zone 4341
NMPA Releases Technical Guideline for Clinical Trial Endpoints for the Advanced NSCLC 44 ............. 42
NMPA officially joined national competent authority report (NCAR) exchange program of IMDRF45 ..... 42
Regulations of People's Republic of China on Management of Human Genetic Resources on June 10,
201946 ...................................................................................................................................................... 43
CDE Announces Public Consultation on “Working Procedure for Breakthrough Therapy Designated
Drugs”, “Working Procedure for Priority Review and Approval”, Technical Guidelines for Conditional
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Marketing Approval Granted to Urgently Needed Drugs in Clinical Practice (Draft for Comments), as
well as Explanatory Notes on Nov. 8, 201947 .......................................................................................... 43
CDE Announces Public Consultation on Technical Guidelines for Clinical Changes to Already Marketed
Drugs on Nov. 8, 201948 .......................................................................................................................... 43
CDE Announces Public Consultation on Technical Guidelines for Researches Regarding
Pharmaceutical Changes to Already Marketed Chinese Medicine, ........................................................ 43
Technical Guidelines for Researches Regarding Pharmaceutical Changes to Already Marketed
Chemical Drugs and Technical Guidelines for Researches Regarding Pharmaceutical Changes to
Already Marketed Biologics (Draft for Comments) on Nov. 8, 201949 ..................................................... 44
NMPA Circular on Adopting 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess
Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening on Nov. 12 201950
................................................................................................................................................................. 44
NMPA Circular on Adopting 13 ICH Guidelines Including SIA: Guideline on the Need for
Carcinogenicity Studies of Pharmaceuticals on Nov.12, 201951 ............................................................. 44
NMPA and NHC Releases “Administrative Measures for Drug Clinical Trial Organizations”on Nov. 29,
201952 ...................................................................................................................................................... 44
NMPA Circular on Guarantee the Record Filing Procedure for Drug Clinical Trial Organizations Nov. 29,
201953 ...................................................................................................................................................... 45
State Administration for Market Regulation (SAMR) SAMR Announces New Public Consultation on
“Regulations on Drug Registration (Draft for Comments)” and Explanatory Note on the Issuance of
Regulations on Drug Registration (Draft for Comments) on Dec. 10, 201954 ......................................... 45
NMPA Releases Guidance for Using Real-World Evidence to Support Drug R&D and Regulatory
Review (Interim) and Explanatory Note to Guidance for Using Real-World Evidence to Support Drug
R&D and Regulatory Review (Interim)55 .................................................................................................. 45
CDR-ADR Circular on the Launch of E2B (R3) Electronic Transmission System56 ................................ 46
NMPA Circular on Implementation of 11 ICH Guidelines Including Q2(R1) - Validation of Analytical
Procedures: Text and Methodology57 ...................................................................................................... 46
NMPA Circular on Recommended Implementation of 4 ICH Guidelines Including “Q8 (R2) –
Pharmaceutical Development”58 .............................................................................................................. 46
CDE Circular on Adjusting Administrative Procedures Regarding Drug Registration Application
Acceptance, Dossier Submission, and Information Support Service During Novel Coronavirus Outbreak
on Feb.2, 202059 ...................................................................................................................................... 46
SAMR Circular on Releasing “Forms and Templates Required During Examination and Approval of
Advertisements for Drugs, Medical Devices, Health Food and Formula Food for Special Medical Use”
on Feb 28, 201960 .................................................................................................................................... 47
NMPA Announces Public Consultation on “Guidance for Quality Agreement of Contract Drug
Manufacturing (Draft for Comments)” and “Reference Template for Quality Agreement of Contract Drug
Manufacturing (Draft for Comments)” on March 2, 202061 ...................................................................... 47
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NMPA Announces Public Consultation on “Working Procedures for Inspection of Drug Marketing
Authorization Holders (Draft for Comments)” and “Key Points for Inspection of Drug Marketing
Authorization Holders (Draft for Comments)” on March 2, 202062 .......................................................... 47
SAMR Circular on 2020 Annual Legislation Program on March 17, 202064 ........................................... 48
NMPA Announcement on Administrative Regulations on Extended Clinical Trials for Medical Devices
(Interim) and Explanatory Note to “Administrative Regulations on Extended Clinical Trials for Medical
Devices (Interim)”65 .................................................................................................................................. 48
State Administration for Market Regulation (SAMR) SAMR Announces Regulations on Drug
Registration and NMPA Announcement on Implementing “Regulations on Drug Registration” 66 ......... 49
SAMR Announces Regulations on Supervision of Drug Manufacture on March 30, 202067 .................. 50
NMPA Announcement on Matters Concerning the Implementation of the Newly Revised “Regulations
on Supervision of Drug Manufacture” on March 31, 202068 .................................................................... 50
Explanatory Note to Policies in “Regulations on Supervision of Drug Registration”69 ............................ 50
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials for R&D of Drugs
Targeting Community Acquired Bacterial Pneumonia” and “Technical Guidance on Clinical Trials for
R&D of Antimicrobial Agents Targeting Acute Bacterial Skin and Skin Structure Infection” on March 19,
2020 70 ..................................................................................................................................................... 51
CDE Announces Public Consultation on “Guidance for Clinical Trials on Adalimumab Injection
Biosimilars (Draft for Comments)” on Apr. 1, 202071 ............................................................................... 51
CDE Announces Public Consultation on “Guidance for Clinical Trials on Trastuzumab Injection
Biosimilars (Draft for Comments)” on Apr. 7, 202072 ............................................................................... 51
CDE Announces Guidance for Clinical Trials on Pertuzumab Injection Biosimilars (Draft for Comments)
on Apr.17, 202074 .................................................................................................................................... 52
CDE Announces Public Consultation on “Technical Guidance on Clinical Trial Imaging Endpoint
Process Standards for Anticancer Drugs (Draft for Comments)” on Apr.22, 202075............................... 52
NHC Circular on Releasing “Administrative Regulation on National List of Drugs in Shortage (Interim)”
on Apr. 20, 202076 ................................................................................................................................... 53
NMPA and NHC Joint Announcement on Releasing “Good Clinical Practice for Drugs” on Apr.23,
202077 ...................................................................................................................................................... 53
CDE Announces Public Consultation on ICH Guideline “Impurities: Guideline for Residual Solvents
Q3C(R8) ”on Apr.29, 202078 .................................................................................................................... 53
NMPA Announces Public Consultation on Regulatory Documents Including “Basic Requirements and
Review Key Points Regarding Application Procedure and Dossier for Re-registration of Domestically
Manufactured Drugs (Draft for Comments)” on Apr.29, 202079 .............................................................. 54
NMPA Announces Public Consultation on “M4 Module 1 Administrative Documents and Drug
Information” (Draft for Comments) on Apr.29, 202080 ............................................................................. 54
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NMPA Announces Public Consultation on “Basic Requirements for Drug Registration Application
Dossier (Draft for Comments)”on Apr.29, 202081 .................................................................................... 54
NMPA Announces Public Consultation on “Technical Guidelines for Clinical Changes to Already
Marketed Drugs (Draft for Comments)” on Apr.29, 202082 ..................................................................... 54
NMPA Releases “List of Reference Preparations for Generic Drugs (27th List) on Apr.29, 202083 ....... 54
NMPA Announces Public Consultation on 6 Regulatory Documents Including “Special Regulations on
the Administration of Chinese Medicine Registration” on Apr. 29 202084 ............................................... 54
NMPA Announces Public Consultation on Regulatory Documents Including “Classification System for
Registration of Chemical Drugs and Requirements for Application Dossier” on Apr. 29 202085 ............ 55
NMPA Announces Public Consultation on 7 Regulatory Documents Including “Classification System for
Registration of Biologic Products and Requirements for Application Dossier (Draft for Comments)” .... 55
On Apr. 29 202086 .................................................................................................................................... 56
CDE Announces Public Consultation on “Review Guidelines for the Acceptance of Active
Pharmaceutical Ingredient (API) Registration” on Apr. 30 202087 .......................................................... 56
CDE Announces Public Consultation on “Administrative Measures for the Communication on Drug R&D
and Technical Review (Draft for Comments)” on Apr. 30 202088 ............................................................ 56
CDE Announces Public Consultation on “Procedures for Review and Approval of Drug Conditional
Marketing Authorization (Draft for Comments)” on Apr. 30 202089 ......................................................... 56
CDE Announces Public Consultation on “Regulations on Associated Review and Approval of
Pharmaceutical Active Ingredients, Pharmaceutical Excipients, Pharmaceutical Packaging Materials
and Drug Preparations (Draft for Comments)” on Apr. 30 202090 ........................................................... 56
CDE Announces Public Consultation on “Clinical Requirements for Drugs Listed Overseas but Not Yet
Marketed Domestically” Apr. 30 202091 ................................................................................................... 57
Apr. 22 202092 ......................................................................................................................................... 57
CDE Announces Public Consultation on “Guideline on the Submission of Clinical Trial Data (Draft for
Public Review)” on May 6, 202093 ........................................................................................................... 57
CDE Releases “Technical Guideline for Studies of Nitrosamine Impurities in Chemical Drugs (Interim)”
on May 8, 202094 ..................................................................................................................................... 57
CDE Announces Public Consultation on “Technical Guidelines on Preparing Safety Data Submission
for Innovative Anti-Tumor Drug Marketing Application (Draft for Comments)” on May 9, 202095 ........... 57
NMPA Circular on Requiring Quality and Efficacy Consistency Evaluation of Generic Injectable Drugs
on May 12, 202096 ................................................................................................................................... 58
CDE Announces Public Consultation on “Guideline on Adaptive Designs for Clinical Trials (Draft for
Public Review)” on May 13, 202097 ......................................................................................................... 58
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CDE Announces Public Consultation on “Management System for Drug Clinical Trial Registration and
Information Communication” and “Provisions on Requirements and Management of Development
Safety Update Report” on Nov 8, 201998 ................................................................................................. 58
NIFDC Announces Public Consultation on “Testing Procedures and Technical Requirements for Drug
Registration (Draft for Comment)” on May 15, 202099 ............................................................................ 58
NMPA Releases “Technical Review Guideline for the Registration of Dengue Virus Nucleic Acid
Detection Reagents” on May 14, 2020100 ................................................................................................ 59
Technical Guidance for Using Real-World Evidence to Support R&D and Regulatory Review of
Pediatric Drugs (Draft for Comments) on May 18, 2020101 ..................................................................... 59
NMPA Releases “Evaluation Guideline for Raw Material Changes to Passive Medical Devices” May 19,
2020102 ..................................................................................................................................................... 59
CDE Announces Public Consultation on “Guidance for Clinical Trials on Tocilizumab Injection
Biosimilars (Draft for Comments)” May 21, 2020103 ................................................................................ 59
CDE Announces Public Consultation on “Technical Guidance for Communications on Clinical Aspects
Before the Initiation of Key Experiments During the Registration of Innovative Anticancer Drugs
Supported by Single Arm Trials (Draft for Comments)” May 22, 2020104 ................................................ 60
CFDI Announces Public Consultation on Two Regulatory Documents Including “Regulations on
Implementation Principles and Procedures of Drug Registration Inspections (Draft for Comments)” May
22, 2020105 ............................................................................................................................................... 60
CDE Notice on Gradually Restoring Office Administrative Services May 22, 2020106 ............................ 60
CDE Releases “Guidance on Clinical Trial Design for Biosimilars of Liraglutide Injections”on May 28,
2020107 ..................................................................................................................................................... 61
NMPA Releases “List of Reference Preparations for Generic Drugs (28th List)” on May 28, 2020108 ... 61
CDE Announces Public Consultation on “Technical Requirements Concerning Common
Pharmaceutical Issues in Application for Phase I Clinical Trials of Innovative Chemical Drugs (Draft for
Comments)” and “Summary Table for Information of Pharmaceutical Researches Related to Application
for Phase I Clinical Trials of Innovative Chemical Drugs (Revised Version)” on June 1, 2020109 .......... 61
CMDE Circular on Further Regulating the Procedure of Acceptance and Filing Review for Medical
Device Registration on June 5, 2020110 .................................................................................................. 61
CMDE Circular Concerning Imported Medical Device Applying for Registration as Class II Device but
Categorized Under Class III After Technical Review: Registration Application Withdrawal and Follow-up
Procedures on June 5, 2020111 ............................................................................................................... 62
NMPA Announces Public Consultation on “The Measures for record filing regulation of Medical
Representatives (Trial) (Draft for Comments)” on June 5, 2020112 ......................................................... 62
CFDI Announces Public Consultation on “Drug Safety Credit Record Management System for
Nonclinical Safety Evaluation Research Institutes and Clinical Trial Organizations (Draft for
Comments)” on June 5, 2020113 .............................................................................................................. 62
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CDE Announces Public Consultation on the “Guidance on Clinical Trial Design for Biosimilars of
Denosumab Injections (Osteoporosis as Indications) (Draft for Comments)” June 5, 2020114 ............... 62
CDE Announces Public Consultation on “Technical Guidance for Communications Before Marketing
Approval Application on Clinical Aspects Concerning Innovative Anticancer Drugs Supported by Single
Arm Trials (Draft for Comments)” on June 5, 2020115 ............................................................................. 63
NMPA CDE Announces “The Administrative Measures for External Experts of CDE” and “The List of
The First Batch of CDE (No. 4 of 2020)” on June 5, 2020116 .................................................................. 63
NMPA Releases “Guideline on Management and Archiving of Required Documentation for Drug
Clinical Trials” June 5, 2020117 ................................................................................................................ 64
CDE Announces Public Consultation on “Guideline on Pharmaceutical Development of Medicines
(Chemical Drugs) for Paediatric Use (Draft for Comments)” on June 12, 2020118 .................................. 64
NMPA Releases “List of Reference Preparations for Generic Drugs (29th List)” ................................... 64
June 16, 2020119 ...................................................................................................................................... 64
Circular on the Release of “General Requirements for Biosafety of Vaccine Manufacturing Sites” on
June 18, 2020120 ...................................................................................................................................... 64
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials for Modified New
Chemical Drugs (Draft for Comments)” on June 24, 2020121 .................................................................. 64
CDE Announces Public Consultation on “Technical Guidance on Endpoints of Clinical Trials for
Advanced Hepatocellular Carcinoma (Draft for Comments)” on June 24, 2020122 ................................. 65
NMPA Announces Launch of “Drug Registration application software (2020 version)” on June 24,
2020123 ..................................................................................................................................................... 65
CMDE Notice on Information Support Service During July and August 2020: Technical Consultation
Before Medical Device Registration Application on June 22, 2020124 ..................................................... 65
CDE Announces Public Consultation on “Guidance on Designing Clinical Trials for GnRH Agonists in
the Treatment of Advanced Prostate Cancer” on June 28, 2020125 ........................................................ 65
CHP Circular on Implementing "Chinese Pharmacopoeia Pharmaceutical Excipient Monograph
Guardianship Mechanism” on June 17, 2020126 ...................................................................................... 65
NMPA Releases “Classification System for Registration of Biologic Products and Requirements for
Application Dossier” on June 29, 2020127 ................................................................................................ 66
NMPA Releases “Classification System for Registration of Chemical Drugs and Requirements or
Application Dossier” on June 29, 2020128 ................................................................................................ 66
NMPA Circular on Updating Drug Registration Fee Charging Standards on June30, 2020129 ............... 66
NIFDC Circular on Releasing “Testing Procedures and Technical Requirements for Drug Registration
(Interim) (Version 2020)” and Related Matters on July 1, 2020130 .......................................................... 66
NMPA Releases “Revised Appendix to Good Manufacturing Practice for Drugs (2010 Revision) – Blood
Products” June30, 2020131 ...................................................................................................................... 67
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The Chinese Pharmacopoeia Commission Releases “Working Procedures for Drug Generic Name
Review and Approval” on July 1, 2020132 ................................................................................................ 67
NMPA and NHC Circular on Publishing “Pharmacopoeia of the People’s Republic of China (Edition
2020)” on June 24, 2020133 ..................................................................................................................... 67
M4 Module 1 Administrative Documents and Drug Information on July 1, 2020134 ................................ 67
CDE Releases “Rules on Assessment and Management of Safety Information During Drug Clinical
Trials (Interim)” on July 1, 2020135 ........................................................................................................... 67
CDE Releases “Administration Rules on Development Safety Update Reports (Interim)” on July 1,
2020136 ..................................................................................................................................................... 67
CDE Releases “Administration Rules for Drug Clinical Trial Registration and Information
Communication (Interim)” on July 1, 2020137 .......................................................................................... 68
CDE Releases “Review Guidelines for the Acceptance of Chemical Drug Registration (Interim)” on July
2, 2020138 ................................................................................................................................................. 68
CDE Releases “Guidelines for the Acceptance of Biological Product Registration” on July 2, 2020139 . 68
CDE Announces Public Consultation on “General Format and Guidance for Preparing Drug Technical
Documents: ‘Manufacturing Process’, ‘Quality Standards’ and ‘Package Insert’ (Drafts for Comments)”
on July 6, 2020140 .................................................................................................................................... 68
CDE Announces Public Consultation on “Technical Guideline on Clinical Trials for Immune Cell
Therapy Products (Draft for Comments)” on July 6, 2020141 .................................................................. 68
The NMPA Releases Three Regulatory Documents Including “Working Procedure for Review and
Approval of Breakthrough Therapy Designated Drugs (Interim)” on July 7, 2020142 .............................. 69
CDE Notice on New Version of Drug Clinical Trial Registration and Information Release Platform
System on July 10, 2020143 ..................................................................................................................... 69
CDE Releases “Drug Registration Application Dossier Format, Stylistic Rules and Layout Standards” on
July 8, 2020144 ......................................................................................................................................... 69
CDE Releases “Guideline for Management of Drug Clinical Trials During the Covid-19 Outbreak
(Interim)” on July 14, 2020145 ................................................................................................................... 69
CDE announces Public Consultation on “Technical Guideline for Pharmaceutical Changes to Innovative
Drugs (Chemical Drugs) During Clinical Trials (Draft for Comments)” on July 14, 2020146 .................... 69
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials for Antineoplastic Drugs
Used in Combination Therapy” on July 17, 2020147 ................................................................................ 69
CDE Announces Public Consultation on “Guidance on Statistical Design in Clinical Trials for
Antineoplastic Drugs” on July 17, 2020148 ............................................................................................... 70
CDE Releases “Guideline on the Submission of Clinical Trial Data (Interim)” on July 20, 2020149 ........ 70
The CDE Releases “Guidance for Clinical Trials on Rituximab Biosimilars” on July 20, 2020150 .......... 70
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CDE Releases “Guidance for Clinical Trials on Trastuzumab Injection Biosimilars” on July 20, 2020151
................................................................................................................................................................. 70
NMPA Announcement on Adoption of “ICH E2C (R2) Guideline: Periodic Benefic-Risk Evaluation
Report (PBRER)” on July 17, 2020152 ..................................................................................................... 70
The Center for ADR Announces Public Consultation on “Application Dossier and Requirements for
Switching Drugs from Prescription to OTC Status (Revision Draft for Comments)” on July 24, 2020153 70
The CDE Releases “Guideline on Non-Inferiority Clinical Trials for Drugs” on July 24, 2020154 ............ 71
NMPA Opinions on Further Improving the Quality and Capacity of Adverse Event Monitoring System for
Medical Products on July 28, 2020155 ..................................................................................................... 71
The CDE Announces Public Consultation on “Technical Guideline for Pharmaceutical Researches on
Transdermal Patch Generics (Draft for Comments)” on July 24, 2020156 ............................................... 71
CDE Announces Public Consultation on 4 Technical Guidance Including “Technical Guidance on
Clinical Trials of Antibacterial Drugs for the Treatment of Complicated Urinary Tract Infection” on July
31, 2020157 ............................................................................................................................................... 71
CDE Announces Public Consultation on “Guidance on Real World Data Used to Generate Real World
Evidence (Draft for Comments)” on Aug. 3, 2020160 ............................................................................... 72
on Aug. 3, 2020161 ................................................................................................................................... 72
CDE Announces Public Consultation on “Guidance on Research and Validation of Aseptic Processing
and Sterilization of Injection Drugs” on Aug. 3, 2020166 .......................................................................... 73
The CDE Under NMPA Releases “Record Filing Procedures and Requirements for Separated
Packaging of Drugs Manufactured Overseas” on Aug. 3, 2020167 .......................................................... 73
NHSA Announces Public Consultation on “2020 Working Plan of Adjusting Drug Catalogue Covered by
National Healthcare (Draft for Comments)” on Aug. 3, 2020168 .............................................................. 73
CDE Announces Public Consultation on “Guidance on Clinical Trial Design for Oncolytic Virus- Based
Drugs” (Draft for Comments)” on Aug. 7, 2020169 ................................................................................... 73
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials of Drugs for the
Treatment of Lipid Metabolism Disorders (Draft for Comments)” on Aug. 10, 2020169 ........................... 74
CDE Notice: Public Consultation on “ICH M7 Guideline: Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Questions and
Answers” and “M7 Q&A Support Document” on Aug. 10, 2020170 .......................................................... 74
CDE Announces Public Consultation on “Technical Guidance on Similarity Assessment and Indication
Extrapolation of Biosimilars (Draft for Comments)” on Aug. 14, 2020171 ................................................ 74
CDE Releases 5 Technical Guidelines Including “Technical Guideline for Research and Development
of Preventive Vaccines Against Covid-19 (Interim)” on Aug. 14, 2020172 ............................................... 74
CDE Announces Public Consultation on 11 Technical Guidance Including “Technical Guidance on
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets” on Aug. 19, 2020173 ...................... 75
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CDE Announces Public Consultation on “Technical Guideline for Researches on Generic Fulvestrant
Injections (Draft for Comments)” on Aug. 19, 2020174 ............................................................................. 75
CDE Announces Public Consultation on “Guidance on Adjusting for Covariates Clinical Trials for Drugs”
on Aug. 19, 2020175 ................................................................................................................................. 75
CDE Notice on Issuing Electronic Administrative Documents for APIs on Aug. 20, 2020176 .................. 75
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials for Influenza Antivirus
Drugs (Draft for Comments)” on Aug. 21, 2020177 .................................................................................. 75
CDE Announces Public Consultation on “Technical Guidance on Clinical Investigations Concerning
Medicines for the Control of Myopia Progression” on Aug. 24, 2020178 .................................................. 75
CDE Announces Public Consultation on “Technical Guidance on Clinical Trials for Human Stem Cell
Based Therapeutic Products and Their Derivatives (Draft for Comments)” on Aug. 24, 2020179 ........... 76
CDE Announces Public Consultation on “Technical Guidance on Drug Immunogenicity Studies (Draft
for Comments)” on Aug. 24, 2020180 ....................................................................................................... 76
CDE Releases “List of Chemical Drugs of Specific Clinical for Which Reference Preparations Cannot
Be Recommended (1st List)” for Public Review on Aug. 24, 2020181 ..................................................... 76
CDE Announces Public Consultation on “Technical Guideline for Nonclinical Studies of Diagnostic
Radiopharmaceuticals (Draft for Comments)” on Aug. 27, 2020182 ........................................................ 76
CDE Announces Public Consultation on “Guidance for Clinical Trials on Omalizumab Injection
Biosimilars (Draft for Comments)” on Aug. 27, 2020183 ........................................................................... 76
CDE Releases “Technical Guidance for Using Real-World Evidence to Support R&D and Regulatory
Review of Pediatric Drugs (Interim)” on Aug. 27, 2020184 ....................................................................... 77
CDE Announces Public Consultation on “Guidance on Enrichment Strategies and Design for Drug
Clinical Trials (Draft for Comments)” on Aug. 27, 2020185 ...................................................................... 77
CDE Releases “Technical Guideline for Testing Minimal Residual Disease During Clinical Trials of
Drugs for Acute Lymphoblastic Leukemia” on Aug. 28, 2020186 ............................................................. 77
CDE Announces Public Consultation on “Guideline for Subgroup Analyses in Clinical Trials for Drugs
(Draft for Comments)” on Aug. 28, 2020187 ............................................................................................. 77
CDE Announces Public Consultation on “Guidance on Clinical Pharmacology Studies for Pediatric Drug
Development” (Draft for Comments)” on Sep. 1, 2020188 ....................................................................... 77
CDE Announces Public Consultation on “Guidance on Clinical Trial Design for Oncolytic Virus- Based
Drugs” (Draft for Comments)” on Aug. 7, 2020189 ................................................................................... 77
CDE Announce Public Consultation on “Technical Guidance on Clinical Trials for Medicines Treating
Age-Related Macular Degeneration” on Sep. 9, 2020190 ........................................................................ 78
CDE Announces Public Consultation on “Technical Guidance on Pharmaceutical Research and
Changes for Biologics During Clinical Trial (Draft Published Online for Comments)” on Sep. 10, 2020191
................................................................................................................................................................. 78
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NMPA and National Intellectual Property Administration Announce Public Consultation on
“Implementation Measures Concerning Early Resolution Mechanism for Drug Patent Disputes (Interim)
(Draft for Comments)” on Sep. 11, 2020192 ............................................................................................. 78
CDE Announces Public Consultation on “Technical Guidance on Drug-Drug Interaction Studies (Draft
for Comments)” on Sep. 11, 2020193 ....................................................................................................... 78
Conclusions ................................................................................................................................................. 79
References .................................................................................................................................................. 81
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Abbreviations
BE Bioequivalence
CDE Center for Drug Evaluation
CFDA Chinese Food and Drug Administration (old name of NMPA)
CMDE Center for Medical Device Evaluation, NMPA
CPP Certificate of Pharmaceutical Product
CROs Contract Research Organisations
EC Ethics Committee
EU European Union
FDA Food and Drug Administration
FIH First in Human
GMP Good Manufacturing Practice
GCP Good Clinical Practice
GQCE Generic drug quality and efficacy consistency Evaluation
HGRAC Human Genetic Resource Administration of China
ICH International Council for Harmonisation
IND Investigational New Drug
MA Marketing Authorisation
MAA Marketing Authorization Application
MAH Marketing Authorization Holder
NDA(s) New Drug Application(s)
NHC National Health Committee
NMPA National Medical Products Administration (formerly CFDA)
NPC National People’s Congress
US United States
VAT Value added tax
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Background
China is currently the second largest pharmaceutical market in the world and was estimated in 2017 to be
worth $122.6 billion. It was also the biggest emerging market for pharmaceuticals with growth tipped to
reach between $145 billion and $175 billion by 20221.
Due to its high potential for growth, China has also become one of the most important regions for global
drug development, but historically the regulatory environment in China was considered highly challenging
for the following reasons:
The Chinese drug registration process differs from that seen in many other countries, in that new
drug applications (NDAs) for all imported drugs, whether marketed overseas or not, are required
to include data from local clinical trials);
Major differences exist between international standards and some local products and
manufacturers as far as quality is concerned;
The timeframe for review and approval of new drugs is longer than for most major countries;
A lack of capacity in the regulatory body has resulted in a backlog of applications.
In August 2015, the China State Council released “Opinions on Reforming the Review and Approval
System for Drugs and Medical Devices.” The intention of this reform was to promote a structural change
and upgrade of the pharmaceutical industry and bring products already marketed in China up to
international standards in terms of efficacy, safety and quality. These reforms aim to:
Eliminate the existing backlog of registration applications;
Establish an environment for maximizing the quality of generic drugs;
Create a framework in China that encourages research and development of new drugs in line
with global development;
Improve the quality and increase the transparency of the review and approval process.
China has a large pharmaceutical industry; it is estimated that there are between 4,500 and 6,000
manufacturers 2, with businesses based on generics, active pharmaceutical ingredients or traditional
Chinese medicine. Most of the manufacturers are small or medium-sized enterprises. There are however
many manufacturing sites in China that meet global Good Manufacturing Practice (GMP) standards.
Previous regulations meant that the Marketing Authorisation Holder (MAH) also had to be the owner of
the manufacturing site. The reform has seen the separation of the activities of MAH and manufacturer
and so the environment is now more flexible allowing research companies to hold the MA whilst
contracting out the product manufacture to a third party.
Generic drugs available in China tend to have several approved manufacturers and there is a sparsity of
official guidance for the generics industry. The China Food and Drug Administration* (CFDA) has
published “restricted” and “promoted” categories of generic drugs suggesting that a more sound control
and guidance of the generics industry is expected.
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There has traditionally been stiff competition in the generics arena, which has meant that local Chinese
companies have not been interested in developing innovative new drugs, thus their current capacity for
such development is low. In the recent past, these companies have relied on bioequivalence (BE) trials
for generic drug registration but with CFDA’s* new requirements they will need to start focusing on
generic quality and efficacy; as such, any data considered inaccurate or incomplete will not be accepted
and therefore there is potential for existing licenses to be withdrawn.
*Note: CFDA became NMPA (National Medical Products Administration) in 2018. CFDA has been used
in this document to relate to any Guidance or procedure that pre-dates the 2018 reforms.
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Reform Impacts: 2016 Table A: Reforms 2016
Reform Detail / Opportunity
Self-inspection of clinical data CFDA announced a self-inspection programme for clinical data, this required MA applicants, contract research
organisations (CROs) and clinical sites to self-inspect. More than 1600 applications pending approval1
This initiative began in July 2015 and uncovered fake and incomplete data which resulted in non-approvals and in
some cases investigations by CFDA.
CFDA used its experts to inspect selected studies that were suspicious in terms of data authenticity.
For future new drug applications, CFDA requires applicants to include a clinical trial self-inspection report,
which CFDA will review.
After 12 months, CFDA reported that around 90% of the backlogged applications had been withdrawn by
applicants or rejected by CFDA4.
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Reform Detail / Opportunity
Priority review In February 2016, CFDA announced a new ‘priority review’ process to encourage new drug innovation to meet
unmet medical needs and to encourage overseas sponsors to plan and perform clinical development in China in
parallel with the US, EU, Japan and other countriesError! Reference source not found.. An updated version was published in 2
017.
‘Priority review’ status can be requested based on the following criteria:
Innovative drug which is not approved anywhere worldwide
Innovative drug where the manufacturing is to be transferred to a site in China
Global clinical trial application to China in parallel with the US or EU
The innovative drug is for HIV/AIDS, viral hepatitis, a rare disease(s), for malignant tumours and for
paediatric indications
The product is a newly launched generic drug.
Positive priority review status provides applicants with ‘priority reviewer resources’ allocated by the Center for
Drug Evaluation (CDE) and priority communication pathways to obtain advice and expedited feedback from the
CDE/CFDA.
CFDA considers that the target approval time for a priority review, from submission, is six months or less however
this is not yet being seen consistently. The scheme seems to have worked well for applications submitted after
February 2016.
On Dec 28, 2017, NMPA updated opinions on priority review with two modifications in the scope, which
are in line with State Council Opinions of Deepening the Reform of the Review and Approval System and
Encouraging the Innovation of Drugs and Medical Devices (6).New drug application with clinical trial
performed by National Clinical Medical Research Center and confirmed by CDE management department
shall be given priority review and approval.
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Reform Detail / Opportunity
Under the circumstances in which there is a major threat to the public health, registration applications for
drugs that have been granted compulsory licensing shall be given priority review and approval. The
specific circumstances under which there is a major threat to the public health and the specific procedures
for initiating compulsory licensing shall be promulgated separately by National Health and Family
Planning Commission together with relevant authorities.
Additional capacity at CDE In 2015 there were only around 70 reviewers to handle an annual load of more than 7,000 drug applications in the
CDE. Following a new hiring exercise, 600 new drug reviewers were in place by the end of 20164.
Additional hiring of reviewers has continued in 2017–2018.
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Reform Detail / Opportunity
Marketing Authorisation Holder
rationalisation / new
classification /definition of new
drugs
MAH system reform ensures that drug research and development institutions can obtain and hold MAs without
needing to own the manufacturing site7.
Encourages drug research and development institutions to transfer manufacturing to an established drug
manufacturer with an associated site inspection in order to validate the manufacturing process.
Major incentive for local new drug innovators in China, who can now hold marketing authorisations
independently.
Reform implemented in a phased manner starting with a trial in ten selected provinces, mostly on China’s
east coast, over three years
Encourages drug researchers/institutions to focus on Research and Development and alleviates the need
to invest in their own manufacturing plants.
Creation of a new classification of drug, “new to the world”, to replace the previous “new to China” category8.
Based on the global marketing authorisation approval status and the location of the manufacturing site(s)
(inside or outside China).
Removes the previous definitions that were based on the specific status in China, and aligns classification
more closely to other regulatory agencies.
Generic drug quality and
efficacy consistency Evaluation
(GQCE)
Generic drug manufacturers are required to start drug consistency research on quality and efficacy; target
completion date by the end of 20189.
Product list has been developed by CFDA that lists which generic drugs need this consistency evaluation.
For evaluation purposes, the comparator product is the “innovator drug,” or a globally recognised similar drug.
Innovator drug means the first marketed drug globally with the full data package to support its safety and efficacy.
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Reform Impacts: 2017
On March 17 2017, CFDA announced its decision to change the requirement on imported drug
registration. The changes are to encourage foreign-developed new drugs to undergo clinical
investigation within China and outside China in parallel, intended to shorten the time period between
approval outside China and approval inside China to meet the need for new drugs for Chinese
patients.
These changes bring China more into line with global standards, processes and timelines. It is
expected that the new policy will have a positive impact on Ex-China sponsors who can develop a full
clinical development program inside China, with significantly shortened regulatory review processes.
The CFDA marketing authorization approval can be in parallel with the US, EU or any other country’s
approval.
It is envisaged that more foreign (ex-China) sponsors will want to conduct research in China and more
foreign new drugs are likely to be approved. There is hope that the changes will encourage foreign
sponsors to invest in China and set up new drug research centers, with an associated increase in
activity for Chinese clinical trial sites and investigators and potentially CROs in China.
Key changes in 2017 are shown in Table B: Reforms 2017.
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Table B: Reforms 2017
Reform Detail / Opportunity
Opening up of first-in-human (FIH)
Phase I trials to global development
This means that for new chemical drugs and new therapeutic biological products foreign
applicants can have a full clinical development plan executed inside China in parallel with the
global development programmeError! Reference source not found..
This change effectively opens an FIH Phase I market in China
.
Note: preventative vaccines still may not undergo a global trial inside China.
Simplified process for gaining a
marketing approval
Previously, foreign-developed new drugs needed three submissions:
Multinational clinical trial submission to request global Phase II or III trial in China;
After the drug had been approved in US or EU and a certificate of pharmaceutical
product (CPP) was available, submission to CFDA to request clinical trial waiver
(requesting exemption from need to do any additional local trials);
NDA submission to CFDA for market approval.
Under the new policy, there is no need for the second submission (clinical trial waiver) and the
sponsor can move directly to the NDA submissionError! Reference source not found..
This simplified process could shorten the whole approval process by about one year.
Clinical trial management 11 CFDA will no longer accredit clinical sites with Good Clinical Practice (GCP).
Opens up potential for clinical sites in all qualified hospitals,
Likely increase in the number of sites able to manage clinical trials
CFDA retains responsibility for site inspections
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Reform Detail / Opportunity
Opens clinical trial market to all qualified hospitals and to social funds, creating increased
capacity for clinical trials in China
Sponsor can sub-contract inspection or audit for sites to check if they are qualified.
Opportunities for CRO QA departments to expand to take on extra work
Improvement in Ethics Committee (EC) process and review
Each region or province may set up a regional EC to guide EC activities and monitor
trials and investigators in the region.
Includes proposal for EC submission and approval prior to investigational new drug
(IND) submission to CFDA/CDE.
For a multi-centre trial, after EC approval by the lead site, other sites can accept lead
site’s approval without repeating review.
With EC review before IND submission, CFDA/CDE reviewers will be able to review
comments from sites, including trial design comments, encouraging a more active
review of protocol by ECs.
Improvement in the clinical trial/IND review process means a pre-submission consultation
meeting between CFDA and the sponsor will be required for all Phase I or Phase III trial
applications. If after 60 working days following submission, there are no comments from
CFDA/CDE, the submission can be considered approved. Any substantial amendment for an
ongoing trial must be submitted to CFDA in timely manner.
Potential for CRO regulatory affairs functions to expand to co-ordinate/lead meetings.
Clinical trial data from studies outside China can be used in China for registration, including
any BE studies for generic drugs approved in the US, or EU or Japan. These studies will be
subject to an on-site inspection by CFDA.
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Reform Detail / Opportunity
Acceleration of drug and medical device
registration review process11
For drugs and medical devices which are indicated for serious life-threatening conditions or for
significant unmet medical needs, where early- or mid-stage clinical data predicts outstanding
clinical benefit, CFDA can grant a conditional approval to allow early marketing in China. The
conditional approval requires an approved risk management plan and a commitment to
complete required clinical trial(s) based on CFDA’s review and conclusion, much the same as
is currently the norm in the EU.
China’s Ministry of Health issued a rare disease list for China (See 2018 section) and set up a
rare disease patient registration process.
The orphan drug and medical device manufacturer/applicant can apply for a clinical
trial waiver or an agreed decrease in trial subject numbers.
For orphan drugs or medical devices that are already approved outside China, CFDA
can issue a conditional approval to allow marketing in China, while the sponsor
completes commitment for clinical trial based on CFDA’s review and conclusion.
Stricter controls on injectable formulations mean that they will not be approved if an oral
formulation of same product already meets clinical needs.
Active pharmaceutical ingredient, excipient and package material management moves from a
specific approval process to a drug master file process.
Brings this in line with the majority of the rest of the world
Support for new drugs to enter the market by encouraging hospitals to give priority to the
purchase of new drugs that have established safety and efficacy data at a reasonable price.
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Reform Detail / Opportunity
The Chinese Government are looking for a process for maintaining an insurance drug
list following price negotiation with the sponsor but in the meantime they have
committed to have new drugs included on the insurance drug list.
Drug and medical device lifecycle
management11
The new MAH policy has been on trial in ten provinces since November 2015.
The MAH holds all responsibilities for the drug development, regulatory and supply
process, including nonclinical, clinical, manufacture, drug quality, marketing and
delivery, clinical use and safety reporting.
The MAH is responsible for safety reporting and should propose the actions to improve
quality control, timely labelling change or other change initiated from safety analysis.
Re-evaluation of marketed injectable drugs for safety, efficacy and quality control is
consistent with the re-evaluation of generic drug quality and efficacy re-evaluation
started in 2016. The purpose is to upgrade drug quality and remove low-quality
products from the market. The same exercise is ongoing for medical devices.
Inspection system for whole regulatory, development and supply process will be put in
place. Nonclinical and clinical process will be inspected by CFDA; manufacturing
process and quality control will be inspected by provincial-level FDA; sales and
marketing processes will be inspected by city-level FDA.
Protecting innovator’s rights11 Establishment of an effective drug-patent system
Every application for drug approval will include a statement on drug patent non-
infringement.
If an applicant is challenging another party’s patent, the applicant should inform the
patent-holder within 20 days after formal submission; the patent-holder should initiate
any necessary legal action against the applicant within 20 days after being informed by
the applicant and, in parallel, inform CFDA.
CFDA can implement a waiting period of up to 24 months while any decision from a
legal process is pending.
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Reform Detail / Opportunity
If no legal decision has been given within 24 months, CFDA has the right to issue the
new MA.
Clinical trial data protection
An applicant can apply for a clinical trial data protection request, along with their NDA
application.
Six-year protection for new drug, ten-year protection for new orphan drug or new
pediatric drug, three-year protection for modified orphan drug or pediatric drug and ten-
year protection for new biological products.
The protection starts from the date of drug approval. Within this protection period,
CFDA will not approve the same drug from different applicants.
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Reform Impacts: 2018
Note: CFDA became National Medical Products Administration (NMPA) in 2018
Table C: Reforms 2018
Reform Detail / Opportunity
NHC release the Rare Disease List The National Health Committee issued the 1st batch list of Rare Diseases on May 11, 2018.
The list is attached as a PDF below: note this is in Chinese, with bilingual disease list.
41) 关于公布第一批罕见病目录的通知.pdf
NMPA was elected as a member of the
ICH Management Committee
On June 7, NMPA issued a notice saying that at the first meeting of the International
Conference on Technical Registration of Human Drugs in Kobe, Japan, NMPA was elected as
a member of the International Council for Harmonisation (ICH) Management Committee12.
Announcement of NMPA on Technical
Guideline for Acceptance of Overseas
Drug Clinical Trial Data (2018, No.52)
On July 10, 2018, NMPA released the final version of “Technical Guideline for Acceptance of
Overseas Drug Clinical Trial Data”13.
As per the Basic Principles for Acceptance of Overseas Clinical Trial Data, applicants
should ensure the authenticity, integrity, accuracy and traceability of overseas clinical
trial data.
The generation process of overseas clinical trial data should comply with relevant
requirement of ICH Good Clinical Practice (GCP).
Applicants should ensure the design of clinical trials are scientific, the quality
management systems of clinical trials comply with the requirements, as well as clinical
data statistical analysis is accurate and integrated.
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Reform Detail / Opportunity
For drugs which undertake research and development synchronously in China and
abroad (ex-China), for which the clinical trials are to be conducted in China, in order to
ensure the scientific nature and validity of clinical trial designs and data statistical
analysis, applicants/sponsors may communicate with CDE before conducting the
pivotal clinical trials so as to ensure that the designs of pivotal clinical trials are
consistent with the basic technical requirements for drug registration in China.
NMPA released the Circular on
Adjusting the Approval Process for Drug
Clinical Trial Evaluation (2018, Circular
50)
Circular 50 was released by NMPA on July 27, 201814.
In order to encourage innovation, speed up the creation of new drugs, meet the needs of public
drug use, and implement the responsibility of the applicant's research and development,
according to the General Office of the CPC Central Committee and the General Office of the
State Council "Opinions on Deepening the Reform of the Examination and Approval System
and Encouraging the Innovation of Pharmaceutical Medical Devices", related to the review and
approval of drug clinical trials:
For drug clinical trial applications in China, if within 60 days from the date of
application acceptance and payment, the applicant has not received a refusal or
questions from CDE, the drug clinical trial may be carried out in accordance with the
submitted clinical trial protocol.
NPC decided that the three-year period
for the MAH pilot project is extended by
one year
On Oct. 26, 2018, in order to better summarize the pilot experience of the MAH pilot project,
and to lay down a good foundation for reform and improvement of the drug management
system, and pave the way for the revision of the Drug Administration Law of the People's
Republic of China, The Sixth Session of the Standing Committee of the 13th National People's
Congress (NPC) decided that the three-year period for the MAH pilot project should be
extended by one yearError! Reference source not found..
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Reform Detail / Opportunity
This pilot project authorized the State Council to launch MAH system in some places at
the 17th meeting of the Standing Committee of the 12th National People's Congress on
November 4, 2015.
This decision came into force on November 5, 2018.
Accelerate approval of urgently needed
overseas new drugs
On October 30, 2018, the NMPA official website issued the "Notice on the Release of the First
Batch of Clinically Urgently Needed New Drugs List"16.
In order to implement the spirit of the meeting of the State Council and speed up the urgent
need for new overseas drugs to enter China, the NMPA and the NHC have formulated the
“Clinical Urgent Need for Overseas Drug Evaluation and Approval Work Procedures”:
There are 8 new overseas drugs which have been approved recently, and the list of
the other 40 new overseas drugs has now been announced in accordance with the
procedures.
临床急需境外新药审评审批工作程序(2018年第79号)_CN_EN.doc
Drugs in the urgently needed new overseas drug list may be submitted in accordance with the
"Clinical Urgent Need for Overseas New Drug Evaluation and Approval Work Procedures", and
the NDA application shall be directly submitted.
The CDE shall establish a special channel to expedite review.
If NDA application has not yet been submitted, the applicant can contact the CDE at
any time for consultation meeting and submit NDA application as soon as possible.
Legislate independent Vaccine
Administration Law17
http://www.nmpa.gov.cn/WS04/CL2101/331940.html
Nov 11 2018 NMPA published draft version of Vaccine Administration Law for public
comments18.
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Reform Detail / Opportunity
Shaken by Changsheng Bio-technology Co in Changchun vaccine scandal (Changsheng Bio-
technology Co, the vaccine manufacturer, which is based in Jilin province, was found to have
committed serious law violations by China's drug authorities in July and August in connection
with the production of a rabies vaccine. The violations included fabricating production records
and using expired ingredients) the Chinese authority will legislate via an independent Vaccine
Administration Law in parallel with pharmaceutical products. The new Vaccine Administration
Law aims to impose "the strictest" regulations on vaccines to ensure the safety and quality of
these products. The new law intends to improve China's vaccine management system and
eliminate regulatory loopholes exposed by the scandal.
Under the released draft, health and drug authorities will supervise the entire production chain
of vaccines. Drug authorities should also be more thorough in inspecting vaccine production
sites. Manufacturers must digitally record data related to production and inspection of vaccines,
and must also certify the authenticity, integrity and traceability of the data, according to the
draft document. Approval procedures and inspections must cover every batch of vaccines
before they enter the market. Authorized institutes must inspect and approve vaccines, and
report to China's top drug authority and provincial-level drug authorities if there are any major
safety or quality risks found, so that they can be dealt with immediately.
Serious violations of the law, such as producing fake or substandard vaccines, will receive
harsh penalties.
CDE website add functions of IND
permission
In Dec 2018, CDE website added new functions on IND to allow the public access to the IND
application (including progress, supplement notice, and download of IND permission) This was
previously accessible by applicant only. So far, 8 IND permissions were public in CDE website
signifying the formal establishment of the system in China.
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Reform Impacts: 2019
Table D: Reforms 2019
Reform Detail / Opportunity
Status of qualification notification of
clinical site for medical device now
available19
From January 1, 2019, all sites participating in a Medical Device Clinical Trial shall complete
their medical device site qualification notification, which was according to “Medical Device
Clinical Study Institution Notification Regulation, [CFDA Notice 2017 No.145], effective from
January 1, 2018, transition period until December 31, 2018.
The status of medical device sites qualification notification is now available in the old
website of NMPA with link as below (data migration ongoing).
http://218.240.145.213:9000/CTMDS/apps/pub/public.jsp#
MAH ADR direct reporting system online This system is associated with the NMPA reform of ADR reporting which emphasises that
MAH is the main responsible body of pharmaceuticals is now online.
High level decision on State Council
executive meeting for oncology and rare
disease drugs20
China will further shorten the time required for the registration and approval of new oncology
drugs and cut prices, a State Council executive meeting chaired by Premier Li Keqiang
decided on February 11, 2019.
Experts will select overseas new drugs to meet urgent clinical needs, while import policies
will be improved for faster launch of the drugs in China.
China will step up efforts to ensure more early diagnosis and treatment of cancer, and offer
preferential value added tax (VAT) policies for drugs for treatment of rare diseases. Starting
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Reform Detail / Opportunity
on March 1, 2019 for the first group of drugs, which includes 21 drugs for treatment of rare
disease, VAT will be 3% to align with oncology drugs.
China to establish collaboration network
for rare disease diagnosis, treatment21
China will establish a national collaborative network of hospitals for rare disease diagnosis
and treatment to promote the early detection and effective treatment of such diseases,
according to a decision by the National Health Commission (NHC).
Comprised of 324 hospitals selected for their capacity and experience in treating patients
with rare diseases, the network will facilitate the timely transfer of difficult and complicated
cases between hospitals and the allocation of quality medical resources for them.
Meanwhile, hospitals in the network are urged to further train medical workers on rare
disease knowledge and clinical skills, focusing on improving their abilities to identify,
diagnose and treat such cases.
China will establish a system for rare disease patients to be registered.
2018 CDE Performance Review Meeting22 In their performance review meeting CDE looked at key achievements in 2018:
enforcement of process reform,
implementation and acceleration of the approval of urgently needed overseas new
drugs16;
reducing approval process time for drug clinical trial evaluation14,
excipient/active ingredient/package material bundling review
China marketed drug catalogue (Orange Book)
GQCE9 and ICH.
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Reform Detail / Opportunity
In 2018, total 7336 applications submitted to CDE, 9796 applications completed
evaluation, backlog application reduced to 3440 applications, which was a reduction
of 14% compared to 2017.
In 2018, a batch of new and effective drugs for public health prevention and control,
oncology, rare diseases and other urgently needed drugs completed the technical review
and approval, which provided motivation for innovation in research in China.
Drug volume purchasing pilot scheme in 4
(municipality cities)+7 (big cities)23
The purpose of the 4+7 volume purchasing is to cut the drug price, increase market access,
support to reform of healthcare system.
Although the National Health Insurance Bureau has successively published explanations for
the policy, this policy still shook the pharmaceutical industry. For mature products entering
into the policy scope, the price pressure is very high and industry is concerned about
whether the purchase price reduction and quantity are complementary.
Innovation is undoubtedly the direction that is very key in the future.
2019 Report on the work of the
government24
2018 Key achievements in healthcare:
Coordinated medical service, medical insurance, and pharmaceutical reforms
continued.
Made steady progress in developing the tiered diagnosis and treatment model.
Raised the level of government subsidies for rural and non-working urban residents'
basic medical insurance and the reimbursement rate of their serious illness
insurance.
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Reform Detail / Opportunity
The reform for evaluation and approval of new medicines was stepped up; the
prices of 17 oncology drugs were slashed and these drugs were included in the
national medical insurance catalogue.
Strengthened oversight over food and drug safety and investigated and took stern
action in defective vaccines cases.
Tasks in 2019:
Strengthen R&D and the application of big data and artificial intelligence
technologies, foster clusters of emerging industries like bio-medicine.
Ensure access to basic medical and health services. Continue to increase basic
medical insurance and serious disease insurance protection for rural and non-
working urban residents. Lower and unify the deductible line for serious disease
insurance, raise the reimbursement rate, and further reduce the burden of medical
care for people with serious diseases and people living in poverty.
Strengthen the prevention and treatment of serious diseases. Take action in cancer
prevention and treatment, and promote preventive screening, early diagnosis and
treatment, and promote breakthroughs in cancer research.
Improve prevention and treatment of common chronic illnesses. Outpatient
medicines for treating high blood pressure, diabetes, etc., will be made
reimbursable under the medical insurance scheme.
Implement and improve the policy on interprovincial on-the-spot settlement of
medical bills through basic medical insurance accounts; enable patients to use their
medical insurance cards for medical treatment in any designated hospital and settle
their bills straight away regardless of the locality.
Continue the reform of public hospitals and encourage the development of privately
run hospitals.
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Reform Detail / Opportunity
Establish a system for remote medical care services, enhance the training of
community medical workers, and improve services provided both under the tiered
diagnosis and treatment model and by contracted family doctors.
Prevention will continue to be a priority.
Maternal and child healthcare services will be improved.
Support the preservation, innovation, and development of traditional Chinese
medicine.
Drugs and vaccines - strengthen the entire process of their regulation from
production to use.
eCTD implementation progress and plan in
China
On Mar 8, CDE presented the eCTD progress and plan in 2019 annual meeting of China
Association of Pharma Equipment.
The China specification and technical requirement are published for public
comments in March 2019.
China eCTD pilot implementation date will be May 2019, no formal implementation
timeline available yet.
In the early phase, submission of dossier will use CD plus hardcopy, then transfer to
gateway submission gradually.
CDE suggested that industry should be well prepared for eCTD.
For cost efficiency, small and medium companies may consider outsourcing (to
CRO).
Medical Device Animal Study Technical
Review Guideline Part I: Decision
Principles25
NMPA issued “Medical Device Animal Study Technical Review Guideline Part I: Decision
Principles” on April 19. The guideline provided the principles considerations on using live
animal for medical devices development, decision tree and listed 12 devices as examples to
discuss if study in live animals is needed:
1. Porous coated bioprosthetic hip prosthesis
2. Electrocardiography machine
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Reform Detail / Opportunity
3. Cross-linked sodium hyaluronate gel for injection
4. Absorbable hernia patch
5. External defibrillation products
6. Ultrasound soft tissue cutting hemostasis system
7. Implantable pacemaker
8. Drug eluting stent
9. Degradable metal screws for internal fixation
10. Stapler
11. Anastomat
12. Absorbable surgical anti-adhesion products
Medical device online registration system
starts in Jun 201926
CMDE (Center for Medical Device Evaluation, NMPA) announced that medical device online
registration system (eRPS) is implemented in Jun 2019. This system allows local Category
3, import Category 2 & 3 medical device registration and Category 3 high risk medical
device clinical trial applications. E-submission is optional and paper dossier under current
requirement are still allowed before Oct 31. From Nov 1, submission dossier including
paper and e-dossier should follow the Table of Contents by International Medical Device
Regulators Forum (IMDRF).
This is the gateway for the online submission. http://erps.cmde.org.cn/
Approval procedure of medical device
clinical trial permit application changed to
implied approval27
On April 1 2019, NMPA issued the Adjustment of Medical Device Clinical Trial Approval
Procedure. Since the date, for clinical trial permit application, if no feedback from NMPA
within 60 working days, sponsor can directly start the clinical trial. NMPA will no longer issue
the trial approval letter. Similar to drug, applicant can download and print the trial approval
letter from NMPA website. If necessary, pre-IND meeting can be required by sponsor.
Other requirements of medical device clinical trial, continuous follow the Registration
Regulation of Medical Device.
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Second batch of clinical urgently needs
oversea new drugs 28
Following the 1st batch released in October 2018, CDE released the 2nd batch of drug
products of urgently medical needs in China on May 29, in which 26 products are included.
If there is no ethnic difference, local clinical trial data can be waived for NDA/BLA.
The new drugs added include orphan drugs, paediatric drugs, also include treatments for
life-threatening diseases for which there is either currently no approved product, or for which
the new drug offers a substantial clinical advantage over existing approved therapies.
The draft list was published for public comments in Mar.
NMPA advancing regulatory science
initiatives in drug and medical device in
China29
In Apr 2019, NMPA initiated the strategic plan of China Regulatory Science project and
identified nine priority areas in first batch. The areas include cell and gene therapy products,
nanomedicine, drug-device combination products, post-market drug safety vigilance and
evaluation, AI devices, new material in medical devices, real world data for medical device,
and safety assessment of Chinese traditional medicine and cosmetics.
Three key objectives for the project are specified: establish 3-5 bases for regulatory science;
initiate key regulatory science projects; introduce series drug evaluation and supervision
policies/tools/standards/methods.
State Council releases legislative work
plan for 201930
State Council announced the China 2019 legislative work plan in May 2019. Four healthcare
related legislation are involved:
1. Regulation of safety in Biotech development (lead by Ministry of Science and
Technology)
2. Regulation of clinical practice management on new technology of biomedical (lead
By NHC)
3. Human Genetic Resource Administration of China (lead by Ministry of Science and
Technology)
4. Revision of Regulation of medical device management (by NMPA)
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CDE solicit public comments on Key
Considerations in Using Real World
Evidence to Support Drug Development31
Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in
health care decisions. In China, CDE has already begun to utilize RWE in the review
practices. This guideline will facilitate industry and CDE to clarify the scope of RWE, explore
the principle of the RWE evaluation, and provide a feasible guidance to use of the RWE.
Key Considerations in Using Real-World Evidence to Support Drug Development(Draft for Public Review).docx
NHC solicited public comments on third
batch of encouraging drug list for
pediatric32
The third batch of encouraging drug list for pediatric selection is led by NHC and national
pediatric expert committees. The screening principles are: not registered in China, urgently
unmet medical needs, evidence-based, expert opinion.
State Council issued the human genetic
resources management regulations33
National regulations on the management of human genetic resources recently released by
the State Council, which will go into effect on July 1. The regulations apply to the collection,
preservation and using of a range of genetic materials containing human genomes and
genes (organs, tissues and cells) and impose requirements on human genetic resource
information (data derived from the genetic resource materials). It is issued to regulate and
encourage reasonable employing of human genetic resources in scientific researches,
developing biological medicine (drugs or medical devices) and improving diagnosis and
treatments. According to the regulations, foreign organizations and individuals, as well as
organizations directly controlled by them, are not allowed to collect or preserve China’s
human genetic resources, nor is providing such resources abroad.
Collecting, preserving, utilizing, and providing human genetic resources abroad should be in
accordance with ethics principles, submit to corresponding ethics investigations, and meet
the technical standards formulated by scientific administrative departments of the State
Council, with no violations on the country’s public health, national security, and public
interests.
Sales of human genetic resources are prohibited, said the regulations.
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It is mentioned in the regulation that “In order to obtain the market approval of relevant drugs
and medical devices in China, international cooperative clinical trials conducted in clinical
institutions using human genetic resources of China, which do not involve the exit of human
genetic resources materials, do not need approval”.
During the period before effective date, applications accepted before 5 pm June 28 2019 will
follow the “old” procedure. Applications accepted after this time point will follow the
procedure in the new regulation.
NMPA published the Medical Device
registration 2018 annual review34
This report summarized the 2018 data of key regulations update, registration project
submission & approval, and key innovative medical devices approval information.
Jiao Hong attended the first BBS
conference on global health in boao
Asia35
In June, 2019, Jiao Hong, Director of the NMPA, attended the first BBS conference on
global health in Boao Asia BBS. Jiao Hong said that China, as an important part of the
global pharmaceutical supply chain, is providing a large number of high-quality
pharmaceutical products to the world. NMPA always gives top priority to public health
protection, adheres to the bottom line of drug safety, promotes innovative development,
improves regulatory capacity, and deepens international cooperation, so as to make every
effort for drug safety and effectiveness and contribute to global health.
During the meeting, Jiao Hong met with who Deputy Director-general Dr. Suzanne Jacobs
and GAVI CEO Dr. Seth Berkley respectively, and had in-depth discussions on topics such
as vaccine regulatory system, drug and vaccine pre-certification, and innovative vaccine
development.
CDE published the Drug registration 2018
annual review36
This report summarized the 2018 data of key technical guidelines, registration project
submission & approval, and key innovative drug approval information.
In 2019, CDE objectives include:
(I) Actively promoting the implementation of various reform tasks
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(II) Performing law-based duties for better drug review & approval
(III) Continue to promote the evaluation system to keep abreast of the international
standards
(IV) Continue to promote the modernization of review system and construction of the CDE
talent team
Vaccine Administration Law approved by
the Standing Committee of the Chinese
People's Congress37
The Vaccine Administrative Law approved in end of June, and effective from December 1,
2019. This is the first law focus on vaccine management that features penalties on the
production and sale of substandard or fake vaccines.
The new law, which is the strictest and most comprehensive on vaccines in China, will cover
the research and development, production, distribution, use, supervision and management
of vaccines in the country.
Background story: Legislate independent Vaccine Administration Law17
NMPA Improvement Policy Concerning
Bundling Review and Approval for Drugs
and the Corresponding Supervision Plan38
NMPA announce a new policy to optimize and replace all former regulations about active
ingredient, excipient and packaging material. The regulation effective on Aug 15, 2019. Any
inconsistency between this policy and the former relevant documents of the
Bundling Review, this policy shall prevail.
Dossier requirement of excipient (trial), packaging material (trial), Product list which
exempted from registration, and basic requirement of annual report are attached.
State Council high level opinion on
building a professional and specialized
team of pharmaceutical products
inspection39
The State Council recently issued a high level opinion on building a team of professional
and specialized team of pharmaceutical drug inspectors.
The document advances improving the pharmaceutical drug inspection system by
establishing national and provincial teams of specialized inspectors.
According to the document, the inspectors will be an important force for strengthening drug
supervision and ensuring drug safety.
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A professional, specialized drug inspection system with full-time inspectors as the main
body and part-time inspectors as the supplement will be established within the next three
years.
Q&A on R&D of Biosimilars40 CDE summarized their considerations on the most frequently asked questions during
biosimilar drug review, and released the Q&A on Jul 31, 2019.
Registration strategy:
Recommend of stepwise development of CMC, pre-clinical and clinical. After completion of
CMC and pre-clinical similarity comparison, suggest to have pre-IND meeting with CDE to
clarify the follow-up studies and study design. Suggest to perform a comparative PK study
first in the stage of clinical research, which is followed up by a process o communication
with CDE before following head to head safety and efficacy studies.
Reference Drug selection:
Highly recommend to select China approved originator as the reference drug. If the
reference drug manufactured by different site (same license holder with originator), the
evidence of comparability with the originator should be approved by CDE before starting
the trial.
Immunogenicity comparative study:
Suggest to collect immunogenicity data in all clinical studies, including PK and PD
studies.
Equivalence margin of clinical similarity comparative study:
The equivalence margin is generally estimated based on the Confidence Interval of the
efficacy of the originator, and is determined with consideration of clinical significance.
Indication extrapolation:
Applicants must provide sufficient scientific evidence to support the application for
indication extrapolation. For the reference drug has been approved for multiple indication, if the candidate drug is
clinically similar to the reference drug through the comparison study, an extrapolation to
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other indications of the reference drug can be considered if the comparative study shows
that the candidate drug is clinical similar to the reference drug. Extrapolation of indications
must be considered case by case according to variety features and sufficiency of data on
similarity.
Indications for extrapolation should be those with clinically related pathological
mechanism and/or identical relevant receptor, together with the same working
mechanism and target. In a clinical comparative test, appropriate indication is selected
and the safety and immunogenicity of indication for extrapolation are fully evaluated.
Prescription Information:
Prescription Information of biosimilar drugs should be drafted generally based on the
consideration not to affect their clinical use and to be conducive to post-marketing safety
monitoring.
Data on the clinical trial in the instructions of biosimilar drugs should reflect effectiveness
and safety rather than similarity. Attention should be paid to the difference of the trade
names of the reference drugs and the biosimilar drugs from the generic names. It is
advised that the generic name instead of its trade name of the reference drugs be used
in the reference to data on clinical studies of reference drugs.
Revision of the Drug Administration Law of
the People's Republic of China 41
The Standing Committee of the National People's Congress on Aug 26 2019 approved the
2nd revision to the Drug Administration Law, the core piece of legislation governing the
pharmaceutical industry in China. The revision, effective as of Dec 1 2019, introduce several
welcome changes to the original Drug Administration Law:
Most of the current regulatory reforms are legally banded in the Law: encourage
clinical value-oriented drug innovation, drug for urgent needs (e.g. rare disease and
severe disease), traditional medicine development, pediatric drug; IND approval
within 60 working days; clinical trial in process control; bundling review; conditional
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approval; priority review; MAH; online drug sell; post market management; risk
management; drug reserve & supply system; build professional and specialized
inspector team, etc.
Update the scope of fake drugs. In general, importing drugs without approval will
still result in serious legal consequences, including the revocation of business
permits. However, importing "a small amount" of drugs that do not cause health
damage or interfere with existing treatment can be exempt from legal
consequences,
Increase penalties for legal violations. Producing and selling fake drugs, for
example, results in suspension of the business and revocation of certificates. A fine
of up to 30 times the value of the products produced or sold will be levied,
compared to the penalty of five times the value that is stipulated in the existing law.
Intelligence property reform is not included in this revision.
As all these updates need details instruction to landing, more regulatory updates is expected
in the future.
NHSA Publishes Drug Catalogue of the
National Basic Medical Insurance, Industry
Injury Insurance and Maternity Insurance42
New version of the National Medical Insurance drug catalogue is released with
comprehensive adjustment made aiming at optimizing the structure, reducing the drug cost
burden of the public and improving the efficiency in the use of medical insurance funds. The
catalogue establishes standard for drug payment by the insurance funds. The circular also
announces a series of decisions regarding the implementation policies, covering the
following aspects: reimbursing standard; implementation on local levels; centralized
procurement and national drug database; price negotiation of drugs entering the catalogue.
The new version will be effective on Jan 1 2020.
Implementation Plan to Support the
Development of Boao International Medical
Tourism Pilot Zone 43
This is the level plan announced on Sep 17, 2019, which is an optimize version of previous
plan in 2013.
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The plan outlined major tasks of the pilot zone, located in Hainan, including developing top
level medical service providers and research institutes and developing quality medical
tourism services.
By 2025, the zone will boast world class medical technologies, equipment and drugs,
according to the plan.
With the new policy, import approval of drug and medical device to the pilot zone will be
faster. Data gathered on clinical use in the zone can be used for future registration in China.
The measure may help to reduce the time for innovative overseas drugs to enter the
domestic market.
The administration is working with the Hainan provincial government to formulate detailed
regulations to promote domestic access of overseas drugs, she said.
NMPA Releases Technical Guideline for
Clinical Trial Endpoints for the Advanced
NSCLC 44
Lung cancer is the number one cause of death among people with malignant tumors in
China. In lung cancer, 85% is non-small cell lung cancer (NSCLC). This guideline provides
the general consideration on different clinical trial endpoints, and expect to give reference to
NSCLC clinical trial design.
NMPA officially joined
national competent authority report (NCAR)
exchange program of IMDRF45
On September 19 2019, IMDRF-16 meeting in Yekaterinburg, Russian, NMPA officially
joined national competent authority report (NCAR) exchange program of IMDRF.
The NCAR Exchange Program facilitates the exchange of relevant post market safety
information on medical devices with global distribution. The aim is to trigger rapid adoption
of field safety corrective actions in all concerned geographies to avoid death or serious
deterioration of health. Up to date, there are more than 20 countries/regions joined this
program.
NMPA next step is share and exchange the information with member countries, timely
obtain serious adverse events of medical device globally, which to secure the safety use of
medical device in China.
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Regulations of People's Republic of China
on Management of Human Genetic
Resources on June 10, 201946
The newly issued national regulations aim at effectively protecting and reasonably utilizing
human genetic resources. The regulations apply to the collection, preservation and using of
a range of genetic materials containing human genomes and genes (organs, tissues and
cells) and impose requirements on human genetic resource information (data derived from
the genetic resource materials). It is issued to regulate and encourage reasonable
employing of human genetic resources in scientific researches, developing biological
medicine (drugs or medical devices) and improving diagnosis and treatments. According to
the regulations, foreign organizations and individuals, as well as organizations directly
controlled by them, are not allowed to collect or preserve China’s human genetic resources,
nor is providing such resources abroad.
CDE Announces Public Consultation on
“Working Procedure for Breakthrough
Therapy Designated Drugs”, “Working
Procedure for Priority Review and
Approval”, Technical Guidelines for
Conditional Marketing Approval Granted to
Urgently Needed Drugs in Clinical Practice
(Draft for Comments), as well as
Explanatory Notes on Nov. 8, 201947
These three guidance documents are issued according to new requirements established in
the updated Regulations on Drug Registration. The drafts are released for public
consultation until November 13 2019. Any suggestions and feedback can be submitted
through the feedback form attached as second reference file and sent to CDE s contact
email boxes.
These notes gives supplementary information on the issuing of this draft guidance,
explaining the background, drafting process, key considerations and major content, and
special issues that need to be highlighted.
CDE Announces Public Consultation on
Technical Guidelines for Clinical Changes
to Already Marketed Drugs on Nov. 8,
201948
This document is intended to give instructions as well as to further regulate studies and
administration on post-approval clinical changes to drugs that are already in the market,
following the newly revised Drug Administration Law. The draft is now released to invite
public review. Any suggestions and feedback should be submitted to CDE s contact email
box before November 13 2019.
CDE Announces Public Consultation on
Technical Guidelines for Researches
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Regarding Pharmaceutical Changes to
Already Marketed Chinese Medicine,
Technical Guidelines for Researches
Regarding Pharmaceutical Changes to
Already Marketed Chemical Drugs and
Technical Guidelines for Researches
Regarding Pharmaceutical Changes to
Already Marketed Biologics (Draft for
Comments) on Nov. 8, 201949
These documents are intended to give instructions as well as to further regulate studies on
post-approval pharmaceutical changes to chemical drugs and biologics that are already in
the market, following the newly revised Drug Administration Law. The drafts are now
released to invite public review. Any suggestions and feedback should be submitted through
the feedback form attached as second reference file to CDE s contact email box before
November 13 2019.
NMPA Circular on Adopting 15 ICH
Guidelines Including E1: Extent of
Population Exposure to Assess Clinical
Safety for Drugs Intended for Long-Term
Treatment of Non-Life-Threatening on Nov.
12 201950
NMPA announces the decision to adopt 15 ICH guidelines of “E Series” in China. The
circular explains specific requirements and effective date of each of these guidelines.
Relevant guidance documents are available on the website of Center for Drug Evaluation
(CDE). These 15 ICH guidelines are listed in the annex.
NMPA Circular on Adopting 13 ICH
Guidelines Including SIA: Guideline on the
Need for Carcinogenicity Studies of
Pharmaceuticals on Nov.12, 201951
NMPA announces the decision to adopt 13 ICH guidelines in China. Applicants are required
to conduct researches following ICH guidelines as soon as possible, but always based on
the current technical requirements. Non clinical studies that start from May 1 2020 should
adopt these 13 ICH non clinical guidelines. Relevant guidance documents are available on
the website of Center for Drug Evaluation (CDE). These 13 ICH guidelines are listed in the
annex.
NMPA and NHC Releases “Administrative
Measures for Drug Clinical Trial
Organizations”on Nov. 29, 201952
NMPA and National Health Commission jointly releases these administrative measures
following the newly established Drug Administration Law. These measures are effective
from December 1 2019.
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NMPA Circular on Guarantee the Record
Filing Procedure for Drug Clinical Trial
Organizations Nov. 29, 201953
This circular is issued following the newly released “Administrative Measures for Drug
Clinical Trial Organizations”, which gives further instructions on the implementation of
these measures. The administration of clinical trial organizations has changed from
qualification accreditation to record filing.
State Administration for Market Regulation
(SAMR) SAMR Announces New Public
Consultation on “Regulations on Drug
Registration (Draft for Comments)” and
Explanatory Note on the Issuance of
Regulations on Drug Registration (Draft for
Comments) on Dec. 10, 201954
This draft regulation is issued to meet the requirements established by the newly released
Drug Administration Law and Law on Vaccine Administration. Any suggestions and
feedback should be submitted through SAMR’s web portal, the authority’s contact email or
by email before December 17 2019. The draft regulation as well as an explanatory note on
its issuance are attached as annexes.
These regulations apply to activities of drug R&D, registration and supervision for the
purpose of marketing authorization. The content contains the following chapters: General
Provisions; Basic Systems and Requirements; Registration for Drug Marketing
Authorization; Accelerating Drug Marketing Authorization; Changes and Re-registration after
Market Approval; Application Acceptance, Supplementary Dossier and Procedure
Withdrawal; Dispute Resolution; Procedure Timing; Administration and Supervision; Legal
Liabilities; Supplementary Provisions.
This note gives further explanations on the issuance of this draft regulation, providing
supplementary information on the following aspects: background and necessity of its
issuance; drafting process; key considerations and major content of the new draft.
NMPA Releases Guidance for Using Real-
World Evidence to Support Drug R&D and
Regulatory Review (Interim) and
Explanatory Note to Guidance for Using
Real-World Evidence to Support Drug R&D
and Regulatory Review (Interim)55
NMPA announces the issuance and release of this guidance document, which is intended to
give further instructions and set requirements regarding the application of real-world
evidence in drug R&D as well as regulatory review/approval. The guidance and an
explanatory note to its issuance are provided as annexes.
This document gives supplementary information on the issuance of this guidance regarding
the background and process of its drafting, as well as further explanation on its major
content.
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CDR-ADR Circular on the Launch of E2B
(R3) Electronic Transmission System56
The Center for Drug Reevaluation and National Center for ADR Monitoring announces the
launch of E2B (R3) electronic transmission system intended for the submission of individual
case safety reports, starting from January 1 2020. Detailed instructions on the submission
process are provided in the “Working Procedure of Individual Case Safety Report
Submission Through E2B (R3) Electronic Transmission System”, which is attached as
annex. There will be trial period for the system operation, during which the previous channel
and requirements for submission remain valid.
NMPA Circular on Implementation of 11
ICH Guidelines Including Q2(R1) -
Validation of Analytical Procedures: Text
and Methodology57
NMPA issues this circular to inform the implementation of 11 ICH guidelines.
Pharmaceutical researches starting 6 months after the publication date of this circular are
required to follow these ICH guidelines, otherwise applicants should follow them as soon as
possible. List of these 11 ICH guidelines and the corresponding Chinese titles is provided as
Annex.
NMPA Circular on Recommended
Implementation of 4 ICH Guidelines
Including “Q8 (R2) – Pharmaceutical
Development”58
NMPA issues this circular to inform the recommended implementation of 4 ICH guidelines:
Q8(R2) - Pharmaceutical Development; Q9 - Quality Risk Management; Q10 -
Pharmaceutical Quality System; Q11- Development and Manufacture of Drug Substances
(Chemical Entities and Biotechnological/Biological Entities). Since the date of publication,
drug applicants are suggested to follow the requirements established in these guidelines in
the product R&D. List of these four ICH guidelines and the corresponding Chinese titles
is provided as Annex.
CDE Circular on Adjusting Administrative
Procedures Regarding Drug Registration
Application Acceptance, Dossier
Submission, and Information Support
CDE has decided to temporarily adjust its administrative services related to drug registration
application, dossier submission and consultation. From February 3 2020: 1). Online
submission platform “Applicant’s Window” will be the channel for submission of electronic
dossier; 2). On-site channels for accepting documents of registration application, corrective
and supplementary submission will be shut down and be replaced by postal service
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Service During Novel Coronavirus
Outbreak on Feb.2, 202059
channel; 3). On-site consultation and information support will be closed and replaced by
telephone communication.
SAMR Circular on Releasing “Forms and
Templates Required During Examination
and Approval of Advertisements for Drugs,
Medical Devices, Health Food and Formula
Food for Special Medical Use” on Feb 28,
201960
SAMR announces to release a compilation of reference forms and templates that are to be
used during the examination and approval of advertisements of drugs, medical devices,
health food and formula food for special medical use. These document models are issued
under the framework of “Interim Administrative Measures for the Examination and Approval
of Advertisements for Drugs, Medical Devices, Health Food and Formula Food for Special
Medical Use”, which are intended to establish unified document format and standards for
administrative procedures. The compilation of documents is provided as Annex.
NMPA Announces Public Consultation on
“Guidance for Quality Agreement of
Contract Drug Manufacturing (Draft for
Comments)” and “Reference Template for
Quality Agreement of Contract Drug
Manufacturing (Draft for Comments)” on
March 2, 202061
NMPA issues these two draft documents following requirements of the newly released
national Drug Administration law. They are intended to give guidance to drug Marketing
Authorization Holders (MAHs) and contracted drug manufacturers in assuming
responsibilities and guarantee product quality. These two draft documents are now released
for public consultation and they are provided as Annexes. Any suggestions and comment
should be submitted to NMPA’s contact email before March 18 2020.
NMPA Announces Public Consultation on
“Working Procedures for Inspection of
Drug Marketing Authorization Holders
(Draft for Comments)” and “Key Points for
Inspection of Drug Marketing Authorization
Holders (Draft for Comments)” on March 2,
202062
NMPA issues these two draft documents to give specific guidance on the implementation of
the newly released national Drug Administration Law and Vaccine Administration Law. They
are intended to further regulate the inspection procedure on drug Marketing Authorization
Holders (MAHs), requiring MAHs to assume responsibilities for drug safety, efficacy and
quality control during manufacturing, distribution and drug use. These two draft documents
are now released for public consultation and are provided as Annexes. Any suggestions and
comment should be submitted to NMPA’s contact email before March 18 2020.
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CDE issued Guidance for Clinical Trials on Rituximab Biosimilars (Draft for Comments) on March 17, 202063
The patent on rituximab in China expired on 2013, following which many manufacturers of
China and overseas have initiated R&D on its biosimilars. This draft guidance is issued
based on “Technical Guideline for Development and Evaluation of Biosimilars (Interim)” as
well as characteristics of rituximab, which is intended to provide technical reference for its
clinical research and development. It covers content of the following aspects: general
introduction; major considerations in clinical research design for rituximab (pharmacokinetics
comparison study; effectiveness comparison study; safety and immunogenicity studies); and
summary.
SAMR Circular on 2020 Annual Legislation
Program on March 17, 202064
The SAMR announces the approval of 2020 annual legislation program and work plan,
which covers 7 final drafts of administrative laws and regulation, revision of 48 ministerial
regulations, and a series of legislative proposals regarding market supervision and
administration. Regulations on drug registration, manufacturing, distribution; release of
biologics; online drug selling; medical device registration, manufacturing, distribution,
adverse event monitoring; IVD registration, etc. are within this annual plan. The circular
establishes procedure and principles for legislation drafting and revision, as well as gives
detailed information on the implementation of the plan. A list of regulations included in the
plan is provided within the circular.
NMPA Announcement on Administrative
Regulations on Extended Clinical Trials for
Medical Devices (Interim) and Explanatory
Note to “Administrative Regulations on
Extended Clinical Trials for Medical
Devices (Interim)”65
These regulations apply to all extended clinical trials for medical devices that are conducted
within China. “Extended clinical Trials” refer to the following practice: For a medical device
that has not been approved for marketing, it is allowed to be used by institutions that are
conducting its clinical trials on patients diagnosed with life-threatening diseases for which
effective treatment is not available yet. The use of medical devices for extended clinical
trials should be based on the observation that existing clinical trials may benefit the subject,
and the patient cannot be admitted to the clinical trials that are already in process because
the selection of participants has been completed. The regulations include the following
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This document was not published and
available on the website of NMPA until March
20, 2020.
chapters: General Principles; Rights and Responsibilities; Conditions for Starting; Procedure
Management; Data Collection; Supplementary Provisions.
This note provides further explanations and guidance concerning some major aspects
established by the newly released regulations: 1). Application scope of extended clinical
trials; 2). Proposal for starting extended clinical trials; 3). Agreement with trial participants;
4). Recording filing; 5). Data submission.
State Administration for Market Regulation
(SAMR) SAMR Announces Regulations on
Drug Registration and NMPA
Announcement on Implementing
“Regulations on Drug Registration” 66
This document was not published and
available on the website of NMPA until March
30, 2020.
These regulations are released under the State Administration for Market Regulation Decree
No. 27 after the approval. They apply to activities of drug R&D, registration and supervision
for the purpose of marketing authorization within China, covering drugs, biologics and
traditional Chinese medicines. The content contains the following chapters: General
Provisions; Basic Systems and Requirements; Registration for Drug Marketing
Authorization; Expedite Approval for Drug Marketing Authorization; Changes and Re-
registration after Market Approval; Application Acceptance, Withdrawal and Dispute
Resolution; Procedure Timing; Administration and Supervision; Legal Liabilities;
Supplementary Provisions.
Effective Date
Jul 1, 2020
The NMPA announcement is issued following the newly released “Regulations on Drug
Registration” as supplementary decision on its implementation, aiming to facilitate a smooth
transition from the old regulation to the new one. The document clarifies regulatory
requirements and gives specific explanations on administrative procedures regarding drug
registration before and after the new regulation take effect.
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SAMR Announces Regulations on
Supervision of Drug Manufacture on March
30, 202067
This document was not published and
available on the website of NMPA until March
30, 2020.
These regulations are released under the State Administration for Market Regulation Decree
No. 28 after the approval. They apply to administrative activities of supervision and
inspection on manufacturing of drugs marketed in China. The content is organized in the
following chapters: General Provisions; Drug Production Permission; Administration of Drug
Manufacture; Supervision and Inspection; Legal Liabilities; and Supplementary
Supervisions.
Effective Date
Jul. 12020
NMPA Announcement on Matters
Concerning the Implementation of the
Newly Revised “Regulations on
Supervision of Drug Manufacture” on
March 31, 202068
This announcement is issued following the newly released “Regulations on Supervision of
Drug Manufacture” as supplementary decision on its implementation. The document clarifies
regulatory requirements and gives specific explanations on administrative procedures
regarding drug manufacturing, license application, approval and renewal etc. before and
after the new regulation takes effect. The announcement includes the following checklists
and forms that are required in the procedures mentioned: 1). Checklist for Drug Manufacture
License Application Dossier; 2). Checklist for GMP Compliance Inspection Application
Dossier; 3). Drug Manufacture License Application Form; 4). GMP Compliance Inspection
Application Form. These checklists and forms are provided as Annexes.
Explanatory Note to Policies in
“Regulations on Supervision of Drug
Registration”69
This note gives further explanations to the issuance of the newly released “Regulations of
Drug Registration” as well as new policies and measures established through a series of
Q&As. It covers key topics including regulation issuing background; issuing purpose and
principles; strengthened supervision on drug life circle; reform on administrative procedures
regarding drug review and approval; new concepts and mechanism introduced; measures to
encourage drug innovation and research, etc.
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CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials for
R&D of Drugs Targeting Community
Acquired Bacterial Pneumonia” and
“Technical Guidance on Clinical Trials for
R&D of Antimicrobial Agents Targeting
Acute Bacterial Skin and Skin Structure
Infection” on March 19, 2020 70
CDE has issued these two draft guidance documents to give technical reference to the R&D
and clinical trials of medicines targeting bacterial infection. Now the administrative authority
is inviting public opinions on these two drafts, which are provided as Annexes. Any
suggestions and feedback should be submitted to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Guidance for Clinical Trials on
Adalimumab Injection Biosimilars (Draft for
Comments)” on Apr. 1, 202071
Currently many companies of China and overseas are in the process of developing
biosimilars of Adalimumab, which was originally developed and marketed by Abbot
Laboratories. This draft guidance is intended to provide technical reference for conducting
clinical researches on Adalimumab biosimilars. The draft guidance is now released online to
invite public opinion. Any feedback and suggestions should be submitted to CDE’s contact
email boxes. The draft guidance is provided as Annex.
CDE Announces Public Consultation on
“Guidance for Clinical Trials on
Trastuzumab Injection Biosimilars (Draft
for Comments)” on Apr. 7, 202072
Trastuzumab, sold under the brand name Herceptin; and originally developed by Roche, is a
monoclonal antibody specially used for cancer that is HER2 receptor positive. Currently
many companies of China and overseas are in the process of developing trastuzumab
Injection biosimilars. This draft guidance is intended to provide technical reference for
conducting clinical researches for developing trastuzumab biosimilars and is now released
online to invite public opinion. Any feedback and suggestions should be submitted to CDE’s
contact email boxes. The draft guidance is provided as Annex.
CDE Announces Guidance for Clinical
Trials on Denosumab Injection Biosimilars
Denosumab entered Chinese market under the brand name Xgeva® in 2019 and its patent
in China will be expired on 2022. Currently many manufacturers in China have initiated R&D
on denosumab injection biosimilars. This draft guidance is issued based on “Technical
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(Malignant Tumors as the Indications)
(Draft for Comments) on Apr. 10, 202073
Guideline for Development and Evaluation of Biosimilars (Interim)” as well as characteristics
of denosumab, which is intended to provide technical reference for its clinical research and
development. This guidance only discusses denosumab biosimilars targeting cancer
patients. It covers content of the following aspects: general introduction; clinical research
strategies for denosumab biosimilars; major considerations in clinical study design
(pharmacokinetics comparison study; effectiveness comparison study; other aspects such
as safety and immunogenicity studies and extrapolation of indications); and summary.
This note gives further information regarding the issuance of this draft guidance on the
following aspects: 1). Background and purpose; 2). Process of issuance; 3). Major content
and key consideration in the guidance.
CDE Announces Guidance for Clinical
Trials on Pertuzumab Injection Biosimilars
(Draft for Comments) on Apr.17, 202074
Pertuzumab entered Chinese market under the brand name Perjeta® in 2018. It is a
monoclonal antibody used in treatment of metastatic HER2-positive breast cancer. The
patent of Pertuzumab will be soon be expired in EU (2023) and US (2024), and currently
many manufacturers in China have initiated R&D on Pertuzumab biosimilars.This draft
guidance is issued based on “Technical Guideline for Development and Evaluation of
Biosimilars (Interim)” as well as characteristics of Pertuzumab, which is intended to provide
technical reference for its clinical research and development. It covers content of the
following aspects: general introduction; clinical research strategies for Pertuzumab
biosimilars; major considerations in clinical study design (pharmacokinetics comparison
study; effectiveness comparison study; other aspects such as safety and immunogenicity
studies); and summary.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trial
Imaging Endpoint Process Standards for
Anticancer Drugs (Draft for Comments)” on
Apr.22, 202075
This draft guidance is issued to set up a standard process regarding the clinical trial imaging
endpoint for the R&D of anticancer drugs, aiming at further regulating industrial standard
and establishing technical requirements. Any suggestions and feedback should be
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submitted through the Feedback Form and sent to CDE s contact email boxes. The form,
the draft guidance and an explanatory note are provided as Annexes.
NHC Circular on Releasing “Administrative
Regulation on National List of Drugs in
Shortage (Interim)” on Apr. 20, 202076
Following “State Council Circular on Guarantee Supplies and Maintaining Prices of Drugs in
Shortage”, NHC has established these administrative measures to further strengthen the
supply and supervision of drugs in shortage. The interim regulation is provided as Annex 1.
Drug shortage that cannot be solved on local level should be reported through the form
provided as Annex 2 to the administration of central government.
NMPA and NHC Joint Announcement on
Releasing “Good Clinical Practice for
Drugs” on Apr.23, 202077
NMPA and NHC have jointly established the new Good Clinical Practice (GCP) for drugs
and now announce its release. This guidance is intended to further regulate research and
clinical trials on drugs as well guarantee the quality of these practices. The guidance
document is provided as Annex.
This guidance applies to clinical trials conducted for the application of drug registration and
regulates activities that are relevant to drug clinical trials. The Good Clinical Practice (GCP)
established here are quality standards for the whole process of clinical trials, covering trial
design, organization and implementation, supervision, inspection, record registration,
analysis, making conclusion and report submission. Content of the document are organized
in the following chapters: General Principles; Terminologies and Definitions; Ethics
Committee; Investigators; Clinical Trial Organizers and Sponsors; Trial Program Design;
Investigator’s Brochure; Management of Required Dossier; Supplementary Provisions.
Effective Date
Jul 1 2020
CDE Announces Public Consultation on
ICH Guideline “Impurities: Guideline for
Residual Solvents Q3C(R8) ”on Apr.29,
202078
This ICH guideline is now in the third stage of regional regulatory consultation and
discussion. The CDE announces to collect opinion on the step 2b draft guideline on regional
level. Any suggestions and feedback should be submitted to CDE s contact email boxes
before the deadline for comments.
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NMPA Announces Public Consultation on
Regulatory Documents Including “Basic
Requirements and Review Key Points
Regarding Application Procedure and
Dossier for Re-registration of Domestically
Manufactured Drugs (Draft for Comments)”
on Apr.29, 202079
Following the NMPA announcement on the implementation of the newly released
“Regulations on Drug Registration”, the administrative authority has drafted these two
regulatory documents concerning re-registration application for domestically manufactured
drugs and drugs manufactured overseas. These two drafts are provided as Annex 1 and
Annex 2. Any suggestions and feedback should be submitted through the feedback form
provided as Annex 3 and sent to NMPA’s contact emails.
NMPA Announces Public Consultation on
“M4 Module 1 Administrative Documents
and Drug Information” (Draft for
Comments) on Apr.29, 202080
The NMPA has decided to revise Module 1 of M4 CTD guidance document following
requirements established in the newly released “Regulations on Drug Registration”. The
draft of the revision is now released to invite public opinion. Any suggestions and feedback
should be submitted to the authority’s contact email box. The draft is provided as Annex.
NMPA Announces Public Consultation on
“Basic Requirements for Drug Registration
Application Dossier (Draft for
Comments)”on Apr.29, 202081
This draft guidance document is issued as a follow up of NMPA announcement on the
implementation of the newly released “Regulations on Drug Registration” to further improve
the administrative procedure. Any suggestions and feedback on the draft should be
submitted through the feedback form provided as Annex 2 and sent to the authority s
contact email box. The draft guidance is provided as Annex 1.
NMPA Announces Public Consultation on
“Technical Guidelines for Clinical Changes
to Already Marketed Drugs (Draft for
Comments)” on Apr.29, 202082
NMPA revised this draft guidance according to requirements established in the newly issued
“Regulations on Drug Registration”. The draft is now released to invite public review. All
suggestions and feedback should be submitted to the authority’s contact email before the
deadline. The draft guidance is provided as Annex.
NMPA Releases “List of Reference
Preparations for Generic Drugs (27th List)
on Apr.29, 202083
The 27th list of reference preparations for generic drugs has been given approval by the
Generic Drug Advisory Committee and now is announced to be released by NMPA. The list
is provided as Annex.
NMPA Announces Public Consultation on 6
Regulatory Documents Including “Special
Regulations on the Administration of
The NMPA has issued the following six draft regulatory documents regarding the
administration and supervision of Chinese medicine registration and marketing: “Special
Regulations on the Administration of Chinese Medicine Registration”, “Classification System
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Chinese Medicine Registration” on Apr. 29
202084
for Chinese Medicine Registration and Requirements for Application Dossier”, “Post-
approval Changes to Marketed Chinese Medicines and Requirements for Application
Dossier”, “Technical Guidelines for Researches Regarding Pharmaceutical Changes to
Already Marketed Chinese Medicines”, “Review Guidelines for the Acceptance of Chinese
Medicine Registration”, and “Review Guidelines for the Acceptance of Chinese Medicine
Post-approval Changes”. All these drafts are now released for public review. Any
suggestions and feedback can be submitted through the online portal, or through feedback
forms provided as Annex 12 then sent to corresponding contact person according to the
information sheet provided as Annex 13. An explanatory note is released for each draft for
further reference. All drafts and notes are provided as Annexes.
NMPA Announces Public Consultation on
Regulatory Documents Including
“Classification System for Registration of
Chemical Drugs and Requirements for
Application Dossier” on Apr. 29 202085
Following the newly issued Regulations on Drug Registration, the NMPA has issued the
following five draft regulatory documents regarding the administration and supervision of
chemical drug registration and marketing approval: Classification System for Registration of
Chemical Drugs and Requirements for Application Dossier; Post-approval Changes to
Marketed Chemical Drugs and Requirements for Application Dossier; Technical Guidelines
for Researches Regarding Pharmaceutical Changes to Already Marketed Chemical Drugs;
Review Guidelines for the Acceptance of Chemical Drug Registration; Review Guidelines for
the Acceptance of Chemical Drugs Post-approval Changes. These drafts together with an
explanatory note for each are provided as Annexes. Any suggestions and feedback can be
submitted through feedback form provided as Annex 6 then sent to NMPA’s contact email
boxes.
NMPA Announces Public Consultation on 7
Regulatory Documents Including
“Classification System for Registration of
Biologic Products and Requirements for
Application Dossier (Draft for Comments)”
Following the newly issued “Regulations on Drug Registration”, the NMPA has issued the
seven draft regulatory documents regarding the administration and supervision of biological
product registration and marketing approval. They cover aspects of registration classification
system, post-approval changes, post-marketing researches on pharmaceutical changes,
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On Apr. 29 202086 review guidelines for acceptance of application. These drafts together with an explanatory
note for issuance are provided as Annexes. Any suggestions and feedback can be
submitted through feedback form provided as Annex 9 then sent to NMPA’s contact email
boxes.
CDE Announces Public Consultation on
“Review Guidelines for the Acceptance of
Active Pharmaceutical Ingredient (API)
Registration” on Apr. 30 202087
These guidelines are drafted following requirements established in the newly issued
“Regulations on Drug Registration”. The draft is now released online to invite public opinion.
Any suggestions and feedback should be submitted through the feedback provided as
Annex 3 and sent to CDE’s contact email boxes. The draft together with an explanatory note
on its issuance are provided as Annex 1 and Annex 2.
CDE Announces Public Consultation on
“Administrative Measures for the
Communication on Drug R&D and
Technical Review (Draft for Comments)” on
Apr. 30 202088
CDE has drafted an updated version of these guidelines to meet new needs from the
industry for a more efficient and faster channel of communication with the administrative
authority during drug registration and review. This draft (provided as Annex) is now released
to invite public consultation. Any suggestions and feedback should be submitted through the
feedback form provided as Annex and sent to CDE s contact email box.
CDE Announces Public Consultation on
“Procedures for Review and Approval of
Drug Conditional Marketing Authorization
(Draft for Comments)” on Apr. 30 202089
These procedures are established to follow up the newly issued “Regulation of Drug
Registration” and as a revision of previous draft version. This draft is now released online to
invite public review. Any suggestion and feedbacks can be submitted through the feedback
from provided as Annex and sent to CDE s email box. The draft together with an
explanatory note to its issuance are also provided as Annexes.
CDE Announces Public Consultation on
“Regulations on Associated Review and
Approval of Pharmaceutical Active
Ingredients, Pharmaceutical Excipients,
Pharmaceutical Packaging Materials and
Drug Preparations (Draft for Comments)”
on Apr. 30 202090
These draft regulations are made according to requirements established in the newly issued
“Regulations on Drug Registration” and now are released online to invite public review. Any
suggestions and feedback should be submitted through the feedback form provided as
Annex and sent to CDE’s email box. The draft together with an explanatory note are also
provided as Annexes.
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CDE Announces Public Consultation on
“Clinical Requirements for Drugs Listed
Overseas but Not Yet Marketed
Domestically” Apr. 30 202091
The administrative authority in China is in the process of accelerating the marketing of brand
name drugs and generic drugs that are already listed overseas in China. This guidance is
drafted to provide technical standard for the industry and regulators. It is now released
online to invite public opinion. Any suggestions and feedback should be submitted through
the annexed feedback form and sent to CDE’s contact email box. The draft guidance is also
provided as Annex.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trial
Imaging Endpoint Process Standards for
Anticancer Drugs (Draft for Comments)”
Apr. 22 202092
This draft guidance is issued to set up a standard process regarding the clinical trial imaging
endpoint for the R&D of anticancer drugs, aiming at further regulating industrial standard
and establishing technical requirements. Any suggestions and feedback should be
submitted through the Feedback Form and sent to CDE s contact email boxes. The form,
the draft guidance and an explanatory note are provided as Annexes.
CDE Announces Public Consultation on
“Guideline on the Submission of Clinical
Trial Data (Draft for Public Review)” on May
6, 202093
This guideline is drafted to further standardize the procedure of drug clinical trial data
submission. Now the draft is released online to invite public opinions. Any suggestions and
feedback should be submitted to CDE’s contact email boxes. The draft guideline together
with an explanatory note to its issuance are provided as Annexes.
CDE Releases “Technical Guideline for
Studies of Nitrosamine Impurities in
Chemical Drugs (Interim)” on May 8, 202094
CDE Releases “Technical Guideline for Studies of Nitrosamine Impurities in Chemical Drugs
(Interim)”
CDE Announces Public Consultation on
“Technical Guidelines on Preparing Safety
Data Submission for Innovative Anti-Tumor
Drug Marketing Application (Draft for
Comments)” on May 9, 202095
These guidelines are intended to provide instructions on the organization, analysis and
summarizing of safety data for innovative anti-tumor drugs that are under applications to be
marketed for the first time. The document gives specific guidance and explanations on data
source; standardization of data presentation and suggestions for adverse reaction
determination; and suggestions for preparing the safety data dossier.
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NMPA Circular on Requiring Quality and
Efficacy Consistency Evaluation of Generic
Injectable Drugs on May 12, 202096
This circular is issued to inform drug marketing authorization holders (MAHs) of NMPA’s
requirements for quality and efficacy consistency evaluations of generic injectable drugs.
For products that are already marketed but have not been reviewed according to principles
of consistency evaluation, the MAH is required to carry out this activity and submit the
application for authority’s review following administrative procedure of “supplementary
application”.
CDE Announces Public Consultation on
“Guideline on Adaptive Designs for Clinical
Trials (Draft for Public Review)” on May 13,
202097
This guideline focuses on the important concepts and principles for adaptive designs in
clinical trials, primarily on the use of adaptive designs in confirmatory clinical trials of
chemical drugs, biological products and traditional Chinese medicines, although the
concepts are also relevant for exploratory studies. It provides guidance to sponsors and
applicants submitting investigational new drug applications, new drug applications, biologics
licensing applications, or supplemental applications on whether and/or how to appropriately
use adaptive designs for clinical trials. Some commonly used adaptive designs will be
discussed from a regulatory perspective, including recommendations for the sponsor to
consider and some specific requirements.
CDE Announces Public Consultation on
“Management System for Drug Clinical
Trial Registration and Information
Communication” and “Provisions on
Requirements and Management of
Development Safety Update Report” on
Nov 8, 201998
These two regulatory documents are issued to meet new requirements established in
relevant regulations: After the application of conducting clinical trials is approved for a drug,
applicants are required to register and update information of the trials as well as submit the
development safety update reports. These two drafts are released for public consultation
until November 15 2019. Any suggestions and feedback should be sent to CDE’s contact
emails through the feedback from attached as second reference document before the
deadline for comments.
NIFDC Announces Public Consultation on
“Testing Procedures and Technical
Requirements for Drug Registration (Draft
for Comment)” on May 15, 202099
This regulatory decision is drafted as supportive document to the newly issued “Regulation
on Drug Registration” to reflect updated requirements concerning testing and inspection
required in drug registrations. The draft decision together with its annexes are now released
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to invite public review and are provided as Annex 1. Any suggestions and feedback should
be submitted through the feedback form provided as Annex 3 and sent to NIFDC s contact
email box. An explanatory note to the issuance is provided as Annex 2.
NMPA Releases “Technical Review
Guideline for the Registration of Dengue
Virus Nucleic Acid Detection Reagents” on
May 14, 2020100
The administrative authority announces to release this technical review guideline expecting
to further improve the efficiency and quality of device registration. The guideline is provided
as Annex.
Technical Guidance for Using Real-World
Evidence to Support R&D and Regulatory
Review of Pediatric Drugs (Draft for
Comments) on May 18, 2020101
This guidance is drafted based on the practical needs of pediatric drug R&D and regulatory
review of China as well as the implementation of ICH E11 (R1). It focuses on major
considerations in using real-word evidence (RWE) to support pediatric drug R&D procedure,
which are applicable to pediatric drugs including chemical drugs, Chinese medicines and
biological products. The document includes content in the following sessions: Introduction;
basic considerations (applicable scope of RWE, application time of RWE; relations between
RWE and common clinical trials; cases of RWEs in supporting the R&D pediatric drugs; and
key aspects worth special attention.
NMPA Releases “Evaluation Guideline for
Raw Material Changes to Passive Medical
Devices” May 19, 2020102
The NMPA announces the issuance and publication of this guideline to further improve the
quality in device registration review and supervision. The guideline is provided as Annex.
CDE Announces Public Consultation on
“Guidance for Clinical Trials on
Tocilizumab Injection Biosimilars (Draft for
Comments)” May 21, 2020103
Tocilizumab, sold under the brand name Actemra® and originally developed by Roche, is a
humanized igG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor
produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Currently
many companies of China and overseas have initiated the development of tocilizumab
Injection biosimilars, and this draft guidance is issued expecting to provide technical
reference for clinical researches of this aspect. Now the draft is released online to invite
public opinion. Any feedback and suggestions should be submitted through the attached
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feedback form and sent to CDE’s contact email boxes. The draft guidance, feedback form
and an explanatory note are provided as Annexes.
CDE Announces Public Consultation on
“Technical Guidance for Communications
on Clinical Aspects Before the Initiation of
Key Experiments During the Registration
of Innovative Anticancer Drugs Supported
by Single Arm Trials (Draft for Comments)”
May 22, 2020104
This draft guidance is issued to encourage drug innovation facilitate the communication of
technical issues between applicants and regulatory authority during the R&D of innovative
anticancer drugs supported by single arm trials. This guidance does not apply to cell therapy
and gene therapy products. Now it is released online to invite public review. Any
suggestions and feedback should be submitted through the attached feedback form and
sent to CDE s contact email boxes. The draft together with an explanatory note to its
issuance are provided as Annexes.
CFDI Announces Public Consultation on
Two Regulatory Documents Including
“Regulations on Implementation Principles
and Procedures of Drug Registration
Inspections (Draft for Comments)” May 22,
2020105
CFDI has drafted these two regulatory documents as supportive documents to the newly
issued Regulation on Drug Registration, specifying general principles, administrative
procedures, timing and requirements for drug inspections during registration; Regulations on
Implementation Principles and Procedures of Drug Registration Inspections; Key Points and
Determination Principles for Drug Registration Inspections. These drafts are now released to
invite public review. Any suggestions and feedback should be submitted through the
attached feedback form and sent to CFDI contact email box. Draft documents, together with
an explanatory note to the issuance and the feedback form are provided as Annexes.
CDE Notice on Gradually Restoring Office
Administrative Services May 22, 2020106
This notice is issued to inform the public that CDE’s administrative services provided in
office that were suspended during the Covid-19 pandemic are partially restored from May 25
2020. The office for dossier submission and pick-up is opened, while on-site consultation
and information service are still suspended. Meanwhile, document submission and
administrative procedures are still encouraged to be carried out through postal service
channel. Visitors to CDE office are required to make appointment in advance by registering
their health information in the form provided as Annex and sending it to CDE’s email box.
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CDE Releases “Guidance on Clinical Trial
Design for Biosimilars of Liraglutide
Injections”on May 28, 2020107
CDE Releases “Guidance on Clinical Trial Design for Biosimilars of Liraglutide Injections”
CDE releases this guidance after the official approval, expecting to give technical guidance
for the R&D of liraglutide injection biosimilars. The guidance together with an explanatory
note to its issuance are provided as Annexes.
NMPA Releases “List of Reference
Preparations for Generic Drugs (28th List)”
on May 28, 2020108
The 28th list of reference preparations for generic drugs has been given approval by the
Generic Drug Advisory Committee and now is announced to be released by NMPA. The list
is provided as Annex.
CDE Announces Public Consultation on
“Technical Requirements Concerning
Common Pharmaceutical Issues in
Application for Phase I Clinical Trials of
Innovative Chemical Drugs (Draft for
Comments)” and “Summary Table for
Information of Pharmaceutical Researches
Related to Application for Phase I Clinical
Trials of Innovative Chemical Drugs
(Revised Version)” on June 1, 2020109
Aiming at encouraging the R&D of new drugs and providing technical reference for common
pharmaceutical issues concerning drug safety that constantly occur during the application
for phase I clinical trials of innovative drugs, the CDE has drafted the Technical
Requirement document and proposed a revision on the “Summary Table for Information of
Pharmaceutical Researches Related to Application for Phase I Clinical Trials of Innovative
Chemical Drugs”, which is the annex part of “Technical Guidance on Phase I New Drugs
Registration” released by the former CFDA in 2018. These two drafts together with an
explanatory note to the issuance and the feedback form are provided as Annexes. Any
suggestions and feedback should be submitted through the feedback form to CDE s email
addresses.
CMDE Circular on Further Regulating the
Procedure of Acceptance and Filing
Review for Medical Device Registration on
June 5, 2020110
The CMDE has this issued this circular to inform device registration applicants of
supplementary requirements related to filing review procedures: In case of lack of
documents in the application dossier, the CMDE will issue a letter with comprehensive
information and applicants should make one single supplementary/corrective submission;
supplementary/correction submission should be made as associated submission to the
initial submission; the regulatory authority will include advices on technical review in the
feedback given for filing review.
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CMDE Circular Concerning Imported
Medical Device Applying for Registration
as Class II Device but Categorized Under
Class III After Technical Review:
Registration Application Withdrawal and
Follow-up Procedures on June 5, 2020111
The CMDE has noted numerous cases in regulatory review of imported device registration
applications that many devices categorized as class II by applicants in submission are
designated as class III device after the technical review by the authority. These applications
with error in classification are required to be withdrawn and re-submitted after correction.
This circular gives specific explanations on how to withdraw submitted application in this
case and how to make new submission after having received feedback from the
administrative authority.
NMPA Announces Public Consultation on
“The Measures for record filing regulation
of Medical Representatives (Trial) (Draft for
Comments)” on June 5, 2020112
To implement the General office of the central committee of the communist party of China
and the General Office of the State Council about "The opinion on deepening the reform of
the review and approval system and encouraging the innovation of drugs and medical
devices ([2017] no. 42)”, to standardize the working behaviour of medical representatives,
NMPA organized to draft “The Measures for record filing regulation of Medical
Representatives (trial) (draft)". Now it is released online to invite public review. Please send
comments via email to [email protected] before June 19, 2020, with the subject line
"Feedback on Measures for record filing regulation of Medical Representatives".
CFDI Announces Public Consultation on
“Drug Safety Credit Record Management
System for Nonclinical Safety Evaluation
Research Institutes and Clinical Trial
Organizations (Draft for Comments)” on
June 5, 2020113
This regulatory document is drafted according to the Regulations for Drug Registration to
establish specific administrative measures for managing drug safety credit record in
nonclinical safety evaluation research institutes and clinical trial organizations. Any
suggestions and feedback should be submitted through the attached feedback form and
sent to CFDI’s contact email box. The draft, together with an explanatory note and the
feedback form are provided as Annexes.
CDE Announces Public Consultation on
the “Guidance on Clinical Trial Design for
Biosimilars of Denosumab Injections
(Osteoporosis as Indications) (Draft for
Comments)” June 5, 2020114
Denosumab, sold under brand name Prolia® for the treatment of osteoporosis and originally
developed by Amgen, is a is a fully human monoclonal antibody directed against receptor
activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation,
and survival of osteoclasts. Currently many companies of China and overseas have initiated
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the development of denosumab Injection biosimilars, and this draft guidance is issued
expecting to provide technical reference for clinical researches of this aspect. Any
suggestions and feedback should be submitted through the attached feedback form and
sent to CDE s contact email boxes. The draft guidance, together with an explanatory note
and the feedback form are provided as Annexes.
CDE Announces Public Consultation on
“Technical Guidance for Communications
Before Marketing Approval Application on
Clinical Aspects Concerning Innovative
Anticancer Drugs Supported by Single Arm
Trials (Draft for Comments)” on June 5,
2020115
This draft guidance is issued based on the “Technical Guidance for Communications on
Clinical Aspects Before the Initiation of Key Experiments During the Registration of
Innovative Anticancer Drugs Supported by Single Arm Trials (Draft for Comments)”, which is
intended to facilitate the communication of technical issues between applicants and
regulatory authority before the submission of marketing approval application. Any
suggestions and feedback should be submitted through the attached feedback form and
sent to CDE s contact email boxes. The draft together with an explanatory note to its
issuance are provided as Annexes.
NMPA CDE Announces “The
Administrative Measures for External
Experts of CDE” and “The List of The First
Batch of CDE (No. 4 of 2020)” on June 5,
2020116
To protect drug approval science fair, give full play to the important role of experts in drug
registration evaluation decision, according to the State Council about “The opinion on the
reform of review and approval system of drugs and medical devices"(guo fa [2015] 44), the
General office of the central committee of the communist party of China and General Office
of the State Council about "The opinion on deepening the reform of the review and approval
system and encouraging the innovation of drugs and medical devices([2017] no. 42)”, and
drug administration relevant regulations of China, CDE has formulate “The Administrative
Measures for External Experts of CDE” (see appendix 1), and approved by NMPA, It is
hereby issued.
In accordance with the prescribed procedures, CDE has organized the selection of external
experts, and with the approval of the NMPA, hereby publish the list of the first batch of
external experts of CDE (see Annex 2). If there is any change in the expert information,
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please inform CDE to update. CDE will continue to carry out external expert selection work,
specific issues will be announced later.
NMPA Releases “Guideline on
Management and Archiving of Required
Documentation for Drug Clinical Trials”
June 5, 2020117
Following requirements established in updated major regulations on drug administration, the
NMPA announces the issuance and release of this guideline expecting to provide technical
instructions on the management of drug clinical trial files. The guideline is provided as
Annex.
CDE Announces Public Consultation on
“Guideline on Pharmaceutical
Development of Medicines (Chemical
Drugs) for Paediatric Use (Draft for
Comments)” on June 12, 2020118
The CDE has drafted this guideline expecting to promote and give instructions to the
development of paediatric medicines. Any suggestions and feedback should be submitted
through the feedback form attached and sent to CDE’s contact email box. The draft
guideline together with a note to its issuance and the feedback form are provided as Annex.
NMPA Releases “List of Reference
Preparations for Generic Drugs (29th List)”
June 16, 2020119
The 29th list of reference preparations for generic drugs has been given approval by the
Generic Drug Advisory Committee and now is announced to be released by NMPA. The list
is provided as Annex.
Circular on the Release of “General
Requirements for Biosafety of Vaccine
Manufacturing Sites” on June 18, 2020120
The circular jointly issued by 5 administrative authorities announces the establishment and
publication of the requirements for vaccine manufacturing biosafety, which are temporary
emergency requirements during the Covid-19 prevention and control. The requirement
document is provided as Annex
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials for
Modified New Chemical Drugs (Draft for
Comments)” on June 24, 2020121
The CDE has drafted this guidance that particularly applies to the category of “modified new
drugs” specified in article 4 on the classification for drug registration in the newly issued
“Regulations for Drug Registration”. It is intended to explain the expected clinical
advantages of drugs under this category and how these advantages can be proved by
clinical trials. The draft guidance together with an explanatory note and a feedback form are
provided as Annexes. Any suggestions and feedback on the draft should be submitted
through the form and sent to CDE’s contact email addresses.
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CDE Announces Public Consultation on
“Technical Guidance on Endpoints of
Clinical Trials for Advanced Hepatocellular
Carcinoma (Draft for Comments)” on June
24, 2020122
The CDE has drafted this guidance expecting to provide technical instructions and
suggestions in clinical research pathways and design for the R&D of drugs targeting
advanced hepatocellular carcinoma. The draft guidance, together with an explanatory note
and a feedback form are provided as Annexes. Any suggestions and feedback should be
submitted through the form and sent to the CDE’s contact email addresses.
NMPA Announces Launch of “Drug
Registration application software (2020
version)” on June 24, 2020123
According to the relevant requirements of the newly released Drug Registration Regulation,
drug registration applicants are required to download the drug registration application
software (Version 2020) in a timely manner from July 1, 2020.
Effective Date
Jul 1, 2020
CMDE Notice on Information Support
Service During July and August 2020:
Technical Consultation Before Medical
Device Registration Application on June
22, 2020124
CMDE releases this notice to inform the public regarding its consultation service available
during July and August of 2020 on medical device registration procedure before submitting
the application. Detailed information on related department and service available timetable
are provided in the notice. The arrangement of consultation service during Covid-19
outbreak will temporarily follow the circular No. CMDE2020/3, which is provided as “Related
Document”.
CDE Announces Public Consultation on
“Guidance on Designing Clinical Trials for
GnRH Agonists in the Treatment of
Advanced Prostate Cancer” on June 28,
2020125
The CDE has drafted this guidance to establish the technical standards, expecting to
provide instructions on the drug R&D process. The draft guidance together with an
explanatory note and a feedback form are provided as Annexes. Any suggestions and
feedback should be submitted through the form and sent to CDE’s contact email boxes.
CHP Circular on Implementing "Chinese
Pharmacopoeia Pharmaceutical Excipient
Monograph Guardianship Mechanism” on
June 17, 2020126
As follow-up measures to the newly issued Chinese Pharmacopeia Version 2020, this
“guardianship mechanism” is to be implemented on the administration of pharmaceutical
excipient standard monograph. The monograph of each pharmaceutical excipient included
in the Chinese Pharmacopeia will be assigned to a responsible “guardian” institute for drug
testing and control to guarantee its implementation. The “guardian” institute has the
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following responsibilities: Providing technical consultation service regarding the application
of pharmacopeia standards; collecting feedback and opinions from the public on the current
pharmacopeia and staying updated with industrial development to coordinate in the
assessment and revision of pharmacopeia standards. The contact information of all
“guardian institutes” and their assigned responsible pharmaceutical excipients are provided
in the Annex.
NMPA Releases “Classification System for
Registration of Biologic Products and
Requirements for Application Dossier” on
June 29, 2020127
The guidance on classification of biologics and submission dossier for product registration is
issued following the new requirements established in the Regulations on Drug Registration.
Apart from announcing the release of this guidance, the circular also specifies the effective
date and requirements for transitional period. The guidance is provided as Annex.
NMPA Releases “Classification System for
Registration of Chemical Drugs and
Requirements or Application Dossier” on
June 29, 2020128
The guidance on classification of chemical drugs and submission dossier for product
registration is issued following the new requirements established in the Regulations on Drug
Registration. Apart from announcing the release of this guidance document, the circular also
specifies the effective date and requirements for transitional period. The guidance is
provided as Annex.
NMPA Circular on Updating Drug
Registration Fee Charging Standards on
June30, 2020129
The NMPA has issued two regulatory documents to reflect the decision of adjusting
administrative fees for drug registration: “Charging Standards for Drug Registration Fees”
and “Implementing Rules for Drug Registration Fees”. For drug registration application
accepted before July 1, 2020, applicants are required to make the payment within 15
working days from July 1 2020. Drug registration fee will be exempt for medicines targeting
the treatment and prevention of Covid19 during the pandemic.
NIFDC Circular on Releasing “Testing
Procedures and Technical Requirements
for Drug Registration (Interim) (Version
2020)” and Related Matters on July 1,
2020130
These requirements are established in line with the newly issued Regulations on Drug
Registration. The NIFDC circular stipulates measures on the implementation of these
requirements, covering aspects of applications submitted before the document issuance;
administrative timeline; registration standard reevaluation; testing reports for drugs and
biologics manufactured overseas; and communication channel with the authorities. The
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“Testing Procedures and Technical Requirements for Drug Registration (Interim) (Version
2020)” is provided as Annex.
NMPA Releases “Revised Appendix to
Good Manufacturing Practice for Drugs
(2010 Revision) – Blood Products” June30,
2020131
The NMPA has revised the Good Manufacturing Practice of Blood Products according to
article 310 of GMP (2010 Revision). Now the new version of GMP- Blood Products is
released as supportive document to the GMP (2010 Revision). The new guidance is
provided as Annex.
The Chinese Pharmacopoeia Commission
Releases “Working Procedures for Drug
Generic Name Review and Approval” on
July 1, 2020132
Following the newly issued “Regulations for Drug Registration”, the Chinese Pharmacopoeia
Commission has issued a set of regulatory decision and guidance on the determination,
review and approval of generic names for innovative Chinese proprietary medicines,
chemical drugs and biological products. These documents apply to the review and approval
of drug generic names as part of certain marketing authorization applications. The decision
and guidance are provided as Annexes 1- 4.
NMPA and NHC Circular on Publishing
“Pharmacopoeia of the People’s Republic
of China (Edition 2020)” on June 24, 2020133
The Pharmacopoeia of China 2020 Edition has been reviewed and approved during the
plenary meeting of the 11th executive committee. The new pharmacopoeia will be effective
from December 30, 2020. Catalogue of 4 volumes that compose the pharmacopeia are
provided as Annexes.
M4 Module 1 Administrative Documents
and Drug Information on July 1, 2020134
CDE has revised the M4 Module 1 document following requirements established by newly
issued regulation on drug administration, drug registration and vaccine administration.
CDE Releases “Rules on Assessment and
Management of Safety Information During
Drug Clinical Trials (Interim)” on July 1,
2020135
The CDE has issued this regulatory document on administrative rules applying to safety
information management during drug clinical trials. These are supportive rules to the newly
released Regulations on Drug Registration. The document is provided as Annex.
CDE Releases “Administration Rules on
Development Safety Update Reports
(Interim)” on July 1, 2020136
The CDE has issued these administrative rules to regulate the creation and management of
“development safety update reports (DSUR)” following the requirements established in the
new Regulations on Drug Registration. The regulation is provided as Annex.
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CDE Releases “Administration Rules for
Drug Clinical Trial Registration and
Information Communication (Interim)” on
July 1, 2020137
The CDE has issued these administrative rules to regulate registration and information
communication concerning drug clinical trials following the requirements established in the
new Regulations on Drug Registration. The regulation is provided as Annex.
CDE Releases “Review Guidelines for the
Acceptance of Chemical Drug Registration
(Interim)” on July 2, 2020138
The CDE has issued these guidelines on authority’s acceptance of chemical drug
registration applications. The guidelines include two parts: Part I applies to drugs under
category 1,2 and 5,1 according to registration classification system; Part I applies to drugs
under category 3, 4 and 5,2. Each part is a separate guideline, and they are provided as
Annex 1 and Annex 2.
CDE Releases “Guidelines for the
Acceptance of Biological Product
Registration” on July 2, 2020139
The CDE has issued these interim guidelines on authority’s review and acceptance of
biological product registration applications. The guidelines include three parts: Part I applies
preventive biological products; Part II applies to therapeutic biological products; and Part III
applies to IVDs that are regulated as biologics. Each part is a separate guideline and is
provided as Annex 1, Annex 2 and Annex3.
CDE Announces Public Consultation on
“General Format and Guidance for
Preparing Drug Technical Documents:
‘Manufacturing Process’, ‘Quality
Standards’ and ‘Package Insert’ (Drafts for
Comments)” on July 6, 2020140
Following the new Regulations of Drug Registrations, the CDE has drafted a set of guidance
documents on the preparation of drug registration application dossier concerning
“manufacturing process”, “Quality Standards” and “Package Inserts” of Chinese medicines,
chemical drugs and biological products. All these draft guidance documents, together with
corresponding explanatory notes and a feedback form are provided as Annexes. Any
suggestions and feedback should be submitted through the form and sent to CDE’s contact
email boxes.
CDE Announces Public Consultation on
“Technical Guideline on Clinical Trials for
Immune Cell Therapy Products (Draft for
Comments)” on July 6, 2020141
The CDE has drafted this guideline as part of technical review system for cellular and gene
therapy products, expecting to provide instructions and reference for drug registration
applicants in product R&D. The draft guideline, together with an explanatory and a feedback
form are provided as Annexes. Any suggestions and feedback should be submitted through
the form and sent to CDE s contact email boxes.
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The NMPA Releases Three Regulatory
Documents Including “Working Procedure
for Review and Approval of Breakthrough
Therapy Designated Drugs (Interim)” on
July 7, 2020142
The NMPA has issued and released the following three interim regulatory decisions
regarding drug prioritized and conditional review and approval as supportive measures to
the implementation of the new Regulations of Drug Registration: “Working Procedure for the
Review and Approval of Breakthrough Therapy Designated Drugs”, “Working Procedure for
Drug Conditional Marketing Authorization Application, Review and Approval” and “Working
Procedure for Drug Prioritized Marketing Authorization Review and Approval”. All three
decisions are provided as Annexes.
CDE Notice on New Version of Drug
Clinical Trial Registration and Information
Release Platform System on July 10,
2020143
The CDE informs that its “Drug Clinical Trial Registration and Information Release Platform
System” has completed the process of update and improvement. A new version is launched
and has started to operate. The new system can be accessed with the same user account
as the one used for “applicant’s window”, but a procedure of account connection is needed.
The notice also provides contact information of CDE for technical support regarding the new
system.
CDE Releases “Drug Registration
Application Dossier Format, Stylistic Rules
and Layout Standards” on July 8, 2020144
The CDE has issued and released these set of rules and standards as supportive document
to the new Regulations of Drug Registration. The regulatory document is provided as Annex.
CDE Releases “Guideline for Management
of Drug Clinical Trials During the Covid-19
Outbreak (Interim)” on July 14, 2020145
This interim guidance is issued to standardize drug clinical trials during the Covid-19
pandemic, aiming to provide safety management measures. The guidance is provided as
Annex.
CDE announces Public Consultation on
“Technical Guideline for Pharmaceutical
Changes to Innovative Drugs (Chemical
Drugs) During Clinical Trials (Draft for
Comments)” on July 14, 2020146
The CDE has drafted this guideline as supportive document to the new Regulations on Drug
Registration. The draft guideline together with an explanatory note and the feedback form
are provided as Annexes. Any suggestions and feedback should be submitted through the
form and sent to CDE’s contact email box.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials for
The CDE has drafted this guidance expecting to provide technical instructions for efficient
R&D of antineoplastic drugs applied in combination therapy. The draft guidance, together
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Antineoplastic Drugs Used in Combination
Therapy” on July 17, 2020147
with an explanatory note and feedback form, are provided as Annexes. Any suggestions and
feedback should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Guidance on Statistical Design in Clinical
Trials for Antineoplastic Drugs” on July 17,
2020148
This draft guidance is issued to facilitate the understanding and application of statistical
design in clinical trials concerning the R&D of antineoplastic drugs. The draft guidance and
an explanatory note to its issuance are provided as Annexes. Any suggestions and
feedback should be submitted to CDE’s contact email addresses.
CDE Releases “Guideline on the
Submission of Clinical Trial Data (Interim)”
on July 20, 2020149
This guideline is issued to further standardize the procedure of drug clinical trial data
submission following the new requirements on drug registration application dossier. The
guideline is effective on October 1, 2020 for chemical drugs and biological products. Its
effective date for Chinese medicines will be explained in “Classification System for Chinese
Medicine Registration and Requirements for Application Dossier”.
The CDE Releases “Guidance for Clinical
Trials on Rituximab Biosimilars” on July
20, 2020150
The CDE has issued and released this guidance after public consultation, expecting to
provide a technical reference for conducting clinical researches on Rituximab biosimilars as
well as establish criteria regarding product technical review. The guidance is provided as
Annex.
CDE Releases “Guidance for Clinical Trials
on Trastuzumab Injection Biosimilars” on
July 20, 2020151
The CDE has issued and released this guidance after public consultation, expecting to
provide a technical reference for conducting clinical researches on developing trastuzumab
biosimilar. The guidance is provided as Annex
NMPA Announcement on Adoption of “ICH
E2C (R2) Guideline: Periodic Benefic-Risk
Evaluation Report (PBRER)” on July 17,
2020152
The NMPA announces that marketing authorization holders (MAHs) can submit periodic
safety update report following the ICH E2C (R2) guideline: Periodic Benefic-Risk Evaluation
Report (PBRER) since publication date of this announcement. Meanwhile, reports prepared
according to national regulations and guidelines are also accepted.
The Center for ADR Announces Public
Consultation on “Application Dossier and
Requirements for Switching Drugs from
Prescription to OTC Status (Revision Draft
for Comments)” on July 24, 2020153
The ADR has drafted this administrative regulation as a revised version on current
regulatory documents following new requirements established in the updated Drug
Administration Law and Regulations for Drug Registration. The draft together with an
explanatory note to its issuance and a feedback form are provided as Annexes. Any
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suggestions and feedback should be submitted through the form and sent to the center’s
contact email box.
The CDE Releases “Guideline on Non-
Inferiority Clinical Trials for Drugs” on July
24, 2020154
The CDE releases this guideline after public consultation to give instructions to sponsor in
understanding, implementing and evaluation non-inferiority clinical for drugs. The guideline
is provided as Annex.
NMPA Opinions on Further Improving the
Quality and Capacity of Adverse Event
Monitoring System for Medical Products on
July 28, 2020155
This policy paper describes NMPA’s five-year plan on strengthening adverse event
monitoring system for drug and medical device through a series of measures concerning a
comprehensive and efficient administrative and regulatory framework; more professional
personnel; an updated monitoring system featuring multichannel for reporting, advanced
function of data analysis and efficient tracking mechanism; and extended international
collaboration. The paper further specifies authority’s action plan on each aspect.
The CDE Announces Public Consultation
on “Technical Guideline for
Pharmaceutical Researches on
Transdermal Patch Generics (Draft for
Comments)” on July 24, 2020156
The CDE has drafted this guideline to specify research considerations and technical
requirements for generics of transdermal patches, which is intended to provide instructions
for registration applicants in product R&D. The draft guideline, together with an explanatory
note to its issuance and a feedback form are attached as Annexes. Any suggestions and
feedback should be submitted through the form to CDE s contact email boxes.
CDE Announces Public Consultation on 4
Technical Guidance Including “Technical
Guidance on Clinical Trials of Antibacterial
Drugs for the Treatment of Complicated
Urinary Tract Infection” on July 31, 2020157
The CDE has drafted 4 technical guidance on clinical trials for antibacterial drugs for the
treatment of uncomplicate urinary tract infection, complicated intra-abdominal infection,
complicated urinary tract infection, and hospital-acquired bacterial pneumonia/ventilator-
associated bacterial pneumonia. All 4 draft guidance together with their corresponding
feedback forms are provided as Annexes. Any suggestions and feedback should be
submitted through the forms and sent to CDE’s contact email boxes.
NMPA Announces Public Consultation on
“Administrative Measures for Post-
Marketing Changes to Drug (Interim) (Draft
for Comments)” on July 31, 2020158
The NMPA has drafted these regulations to further strengthen the administration of post-
marketing changes made to drugs and highlight the responsibility of marketing authorization
holders (MAHs). The draft together with a feedback form are provided as Annexes. Any
suggestions and feedback should be submitted through the form and sent to NMPA’s
contact email box.
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NMPA Announces Public Consultation on
“Interim Regulations for Local Agents of
Overseas Drug Marketing Authorization
Holders (Draft for Comments)” on Aug. 3,
2020159
The NMPA has drafted these interim regulations to strengthen the administration on
activities related to local agents appointed by overseas marketing authorization holders
(MAHs). The draft regulations are provided as Annex. Any suggestions and feedback should
be submitted to the authority s contact email box.
CDE Announces Public Consultation on
“Guidance on Real World Data Used to
Generate Real World Evidence (Draft for
Comments)” on Aug. 3, 2020160
The CDE has drafted this guidance to provide technical suggestions for clinical researches
of therapeutic protein drugs. The draft guidance together with an explanatory note and
feedback form are provided as Annexes. Any suggestions and feedback should be
submitted through the form and sent to CDE s contact email boxes.
CDE Releases “Guidance for Clinical Trials
on Bevacizumab Injection Biosimilars”
on Aug. 3, 2020161
The CDE has issued and published this guidance after public consultation to provide
technical reference for conducting clinical researches on developing bevacizumab
biosimilars. The guidance is provided as Annex
CDE Releases “Guidance for Clinical Trials
on Adalimumab Injection Biosimilars”
on Aug. 3, 2020162
The CDE has issued and published this guidance after public consultation to provide
technical reference for conducting clinical researches on Adalimumab biosimilars. The
guidance is provided as Annex.
Technical Guidance on Pharmacokinetic
Research of Therapeutic Protein Drugs
(Draft for Comments) on Aug. 3, 2020163
This guidance applies to the clinical R&D of therapeutic protein drugs, particularly focusing
on the differences in pharmacokinetics (PK) between therapeutic protein drugs and common
small molecule drugs. It is intended to specify key considerations in PK studies and propose
suggestions in research plan design. Content of the guidance is structured in general
introductions, aspects of PK research and bioanalysis.
CDE Announces Public Consultation on
“Technical Guidance on Bioequivalence
Studies of Drugs with Narrow Therapeutic
Index (Draft for Comments)” on Aug. 3,
2020164
The CDE has drafted this guidance expecting to provide technical suggestions on
bioequivalence studies of narrow therapeutic index drugs with pharmacokinetic parameters
as the primary. The draft guidance together with an explanatory note and feedback form are
attached as Annexes. Any suggestions and feedback should be submitted through the form
and sent to CDE s contact email boxes.
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CDE Announces Public Consultation on
“Technical Guidance on Model-Informed
Drug Development (Draft for Comments)”
on Aug. 3, 2020165
The CDE has drafted this guidance expecting to provide technical suggestions on rational
application of model-informed drug development approach in R&D. The draft guidance
together with an explanatory note and feedback form are attached as Annexes. Any
suggestions and feedback should be submitted through the form and sent to CDE s contact
email boxes.
CDE Announces Public Consultation on
“Guidance on Research and Validation of
Aseptic Processing and Sterilization of
Injection Drugs” on Aug. 3, 2020166
The CDE has drafted this guidance expecting to provide technical suggestions on R&D and
regulatory review on injection drugs. The draft guidance together with an explanatory note
are provided as Annexes. Any feedback should be submitted to CDE s contact email boxes.
The CDE Under NMPA Releases “Record
Filing Procedures and Requirements for
Separated Packaging of Drugs
Manufactured Overseas” on Aug. 3, 2020167
The CDE has issued this regulatory document following new requirements established in
Regulations on Drug Registration. The circular specifies the implementation of new
requirements of record filing for separated packaging of overseas produced drugs before
and after the Regulations on Drug Registration takes effective. The document is provided as
Annex.
NHSA Announces Public Consultation on
“2020 Working Plan of Adjusting Drug
Catalogue Covered by National Healthcare
(Draft for Comments)” on Aug. 3, 2020168
The National Healthcare Security Administration has drafted the 2020 working plan
regarding adjustments to drug reimbursement catalogue covered by the national healthcare
system and invites public review. According to the plan, western medicines, Chinese patent
drugs and herbal decoction pieces will be in the scope of adjustments. Drugs of urgent
clinical needs, generics, pediatric drugs and medicines for the treatment of Covid19 will be
included in the list. A detailed working procedure is also unveiled covering the whole
process of preparation of the catalogue, review and approval, issuing the list of drugs for
price negotiation, price negotiation and confirmation of the list. Any suggestions and
feedback to the draft should be submitted to NHSA s email box.
CDE Announces Public Consultation on
“Guidance on Clinical Trial Design for
Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy
cancer cells, which has shown potentials to provide treatment for many types of malignant
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Oncolytic Virus- Based Drugs” (Draft for
Comments)” on Aug. 7, 2020169
tumors. The CDE has drafted this guidance expecting to give technical suggestions on
clinical design regarding oncolytic virus-based therapy and drugs. The guidance, an
explanatory note and a feedback form are provided as Annexes. Any suggestions and
feedback should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials of
Drugs for the Treatment of Lipid
Metabolism Disorders (Draft for
Comments)” on Aug. 10, 2020169
The CDE has drafted this guidance to provide technical suggestions to support the R&D of
drugs targeting lipid metabolism disorders. The draft guidance together with an explanatory
note and a feedback form are provided as Annexes. Any suggestions and feedback should
be submitted through the form and sent to CDE s contact email boxes.
CDE Notice: Public Consultation on “ICH
M7 Guideline: Assessment and Control of
DNA Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk. Questions and
Answers” and “M7 Q&A Support
Document” on Aug. 10, 2020170
This ICH guideline is now in step 3 for regulatory consultation and discussion. According to
the organization’s procedure requirement, CDE announces the launch of regional regulatory
consultation on these draft documents (step 2b) in China. Any suggestions or feedback can
be communicated in Chinese or English and submitted to CDE s contact email boxes.
CDE Announces Public Consultation on
“Technical Guidance on Similarity
Assessment and Indication Extrapolation
of Biosimilars (Draft for Comments)” on
Aug. 14, 2020171
The CDE has drafted this guidance to provide technical suggestions on the R&D and
regulatory review of biosimilars. The draft together with the feedback form are provided as
Annexes. Any suggestions and feedback should be submitted through the form and sent to
CDE s contact email boxes.
CDE Releases 5 Technical Guidelines
Including “Technical Guideline for
Research and Development of Preventive
Vaccines Against Covid-19 (Interim)” on
Aug. 14, 2020172
The CDE announces to release the following 5 technical guidelines to provide technical
standards concerning R&D of vaccines for the prevention and control of Covid-19 pandemic.
These guidelines cover aspects of vaccine R&D, pharmaceutical research on mRNA
vaccines, non-clinical effectiveness studies and evaluation and clinical evaluation. All 5
guidelines are provided as Annexes.
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CDE Announces Public Consultation on 11
Technical Guidance Including “Technical
Guidance on Bioequivalence Study of
Olanzapine Orally Disintegrating Tablets”
on Aug. 19, 2020173
The CDE has drafted 11 technical guidance on bioequivalence study of the following
generics: Olanzapine Orally Disintegrating tablets, Abiraterone Acetate Tablets, Calcium
Acetate Tablets, Entecavir Tablets, Imatinib Mesylate Tablets, Carbamazepine Tablets,
Leflunomide Tablets, Rivaroxaban Tablets, Sacubitril Valsartan Sodium Tablets, Lanthanum
Carbonate Chewable Tablets, and Vildagliptin Tablets. All 11 draft guidance together with
their corresponding explanatory note to issuance and a feedback form are provided as
Annexes. Any suggestions and feedback should be submitted through the form and sent to
CDE s contact email box.
CDE Announces Public Consultation on
“Technical Guideline for Researches on
Generic Fulvestrant Injections (Draft for
Comments)” on Aug. 19, 2020174
The CDE has drafted this guideline to specify research plan and technical requirements for
generic fulvestrant injections. The draft guideline together with an explanator note and a
feedback for are provided as Annexes.
CDE Announces Public Consultation on
“Guidance on Adjusting for Covariates
Clinical Trials for Drugs” on Aug. 19,
2020175
The CDE has drafted this guidance expecting to facilitate the understanding and technical
requirements regarding the covariate adjustment during clinical trials for drugs. The draft
guidance together with a note to its issuance are provided as Annexes. Any suggestions
and feedback should be submitted to CDE’s contact email boxes.
CDE Notice on Issuing Electronic
Administrative Documents for APIs on
Aug. 20, 2020176
The CDE informs applicants that the electronic API registration system has finished
improvement and upgrading process. Administrative permits and other related documents
for APIs are issued in electronic version from now on and are available through “Applicant’s
Window”.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials for
Influenza Antivirus Drugs (Draft for
Comments)” on Aug. 21, 2020177
The CDE has drafted this guidance based on “Clinical Trials Guidance on Influenza
Treatments” issued in 2012 to provide further technical instructions on drug R&D and
improve clinical accessibility for patients. The draft together with a feedback form are
provided as Annexes. Any suggestions and feedback should be submitted through the form
and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Technical Guidance on Clinical
The CDE has drafted this guidance expecting to give technical suggestions on R&D and
evaluation of medicines for the treatment and control of myopia progression. The draft
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Investigations Concerning Medicines for
the Control of Myopia Progression” on
Aug. 24, 2020178
guidance and a feedback form are provided as Annexes. Any suggestions and feedback
should be submitted through the form and sent to CDE s contact email boxes.
CDE Announces Public Consultation on
“Technical Guidance on Clinical Trials for
Human Stem Cell Based Therapeutic
Products and Their Derivatives (Draft for
Comments)” on Aug. 24, 2020179
The CDE has drafted this guidance as part of its plan for establishing the regulatory review
framework for cell and gene therapy products. The draft guideline, an explanatory note to its
issuance and a feedback form are provided as Annexes. Any suggestions and feedback
should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Technical Guidance on Drug
Immunogenicity Studies (Draft for
Comments)” on Aug. 24, 2020180
Facing the increasing development of therapeutic protein drugs, the CDE has drafted this
guidance to provide technical suggestions to immunogenicity studies during drug R&D.
The draft guidance and an explanatory note to its issuance are provided as Annexes. Any
suggestions and feedback should be submitted to CDE’s contact email boxes.
CDE Releases “List of Chemical Drugs of
Specific Clinical for Which Reference
Preparations Cannot Be Recommended
(1st List)” for Public Review on Aug. 24,
2020181
The CDE has drafted this list following NMPA’s Circular on Requiring Quality and Efficacy
Consistency Evaluation of Generic Injectable Drugs and now publishes it online to invite
public review. The list and a feedback form are provided as Annexes. Any suggestions and
feedback should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Technical Guideline for Nonclinical
Studies of Diagnostic
Radiopharmaceuticals (Draft for
Comments)” on Aug. 27, 2020182
The CDE has drafted this guidance to support and regulate the R&D of diagnostic
radiopharmaceuticals in China. The draft guidance together with an explanatory note to its
issuance and a feedback form are provided as Annexes. Any suggestions and feedback
should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announces Public Consultation on
“Guidance for Clinical Trials on
Omalizumab Injection Biosimilars (Draft for
Comments)” on Aug. 27, 2020183
Omalizumab is a recombinant, humanized, monoclonal antibody against human
immunoglobulin E (IgE). Currently the R&D of omalizumab biosimilars has been initiated by
several manufacturers. This draft guidance is intended to provide technical reference for
conducting clinical researches on developing omalizumab biosimilars and is now released
online to invite public opinion. The draft guidance together with an explanatory note to its
77
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Reform Detail / Opportunity
issuance and a feedback form are provided as Annexes. Any suggestions and feedback
should be submitted through the form and sent to CDE’s contact email boxes.
CDE Releases “Technical Guidance for
Using Real-World Evidence to Support
R&D and Regulatory Review of Pediatric
Drugs (Interim)” on Aug. 27, 2020184
The CDE has issued this guidance to assist researchers in understanding the application of
real-world evidence in the R&D and clinical trials concerning pediatric drugs after the public
consultation on the draft. The guidance is provided as Annex.
CDE Announces Public Consultation on
“Guidance on Enrichment Strategies and
Design for Drug Clinical Trials (Draft for
Comments)” on Aug. 27, 2020185
The CDE has drafted this guidance expecting to facilitate more accurate definition of target
population for drug clinical trials as well as to improve the efficiency. The draft guidance and
an explanatory note to its issuance are provided as Annexes. Any suggestions and
feedback should be submitted to CDE’s contact email boxes.
CDE Releases “Technical Guideline for
Testing Minimal Residual Disease During
Clinical Trials of Drugs for Acute
Lymphoblastic Leukemia” on Aug. 28,
2020186
The CDE has issued this guideline after public consultation on the draft expecting to provide
technical standard for industry regarding the application of minimal residual disease (MRD)
as an important biomarker to measure effectiveness of treatment during the R&D of drugs
for Acute lymphoblastic leukemia (ALL). The guideline is provided as Annex.
CDE Announces Public Consultation on
“Guideline for Subgroup Analyses in
Clinical Trials for Drugs (Draft for
Comments)” on Aug. 28, 2020187
The CDE has drafted this guideline expecting to provide technical advices on exploring
efficacy and safety differences in patients of different characteristics during clinical trials and
evaluating the risk-benefit of subgroups. The draft guideline and an explanatory note are
provided as Annexes. Any suggestions and feedback should be submitted to the CDE’s
contact email boxes.
CDE Announces Public Consultation on
“Guidance on Clinical Pharmacology
Studies for Pediatric Drug Development”
(Draft for Comments)” on Sep. 1, 2020188
The CDE has drafted this guideline to clarify technical requirements for clinical
pharmacology considerations during pediatric drug R&D. The draft together with an
explanatory note to its issuance and a feedback form are provided as Annexes. Any
suggestions and feedback should be submitted through the form to CDE’s contact email
box.
CDE Announces Public Consultation on
“Guidance on Clinical Trial Design for
Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy
cancer cells, which has shown potentials to provide treatment for many types of malignant
78
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Reform Detail / Opportunity
Oncolytic Virus- Based Drugs” (Draft for
Comments)” on Aug. 7, 2020189
tumors. The CDE has drafted this guidance expecting to give technical suggestions on
clinical design regarding oncolytic virus-based therapy and drugs. The guidance, an
explanatory note and a feedback form are provided as Annexes. Any suggestions and
feedback should be submitted through the form and sent to CDE’s contact email boxes.
CDE Announce Public Consultation on
“Technical Guidance on Clinical Trials for
Medicines Treating Age-Related Macular
Degeneration” on Sep. 9, 2020190
The CDE has issued this guidance to give technical advices for the R&D of medicines for
the treatment of age-related macular degeneration (AMD). The guidance is provided as
Annex.
CDE Announces Public Consultation on
“Technical Guidance on Pharmaceutical
Research and Changes for Biologics
During Clinical Trial (Draft Published
Online for Comments)” on Sep. 10, 2020191
The CDE has draft this technical guidance expecting to specify requirements and provide
scientific advices for pharmaceutical researches and changes in this aspect concerning
biologic products during clinical trials. The draft guidance, an explanatory note to its
issuance and a feedback form are provided as Annexes. Any suggestions and feedback
should be submitted through the form and sent to CDE’s contact email boxes.
NMPA and National Intellectual Property
Administration Announce Public
Consultation on “Implementation Measures
Concerning Early Resolution Mechanism
for Drug Patent Disputes (Interim) (Draft for
Comments)” on Sep. 11, 2020192
This draft interim regulation is drafted jointly by two administrative authorities to set specific
measures towards the establishing of patent linkage mechanism. The draft regulation, an
explanatory note to its issuance and a feedback form are provided as Annexes. Any
suggestions and feedback
CDE Announces Public Consultation on
“Technical Guidance on Drug-Drug
Interaction Studies (Draft for Comments)”
on Sep. 11, 2020193
The CDE has drafted this guidance expecting to provide technical advices on designing
drug R&D strategies. The draft guidance, an explanatory note to its issuance and a
feedback form are provided as Annexes. Any suggestions and feedback should be
submitted through the form and sent to CDE’s contact email boxes.
79
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Conclusions
The 2016 - 2019 reforms represent major changes for China’s regulatory environment and are expected
to better align the country with global regulatory norms by:
Reducing the IND (clinical trial) and NDA review timeline.
Strengthening the standards for generic drugs,
Reforming clinical trial data quality requirements and
Introducing a priority review process for innovative drugs,
Accelerate the registration speed for unmet medical needs.
NMPA (formerly CFDA) is clearly encouraging foreign sponsors and applicants to undertake global
studies in China and recommending that local clinical sites are part of global studies to help ensure
clinical trial data meet the requirements needed for China and for global registration. The clinical trial
reforms announced by NMPA will hopefully overcome some of the reluctance of foreign sponsors to
include China in global programs as the IND review timeline of 60 days mirrors that seen outside of
China.
It is anticipated that the new requirements for generic drug quality and efficacy evaluation and self-
inspection of clinical data will upgrade generic drug standards, clinical trial quality and clinical site GCP
compliance. It is acknowledged however that these new standards may also present some initial
challenges for generic pharmaceutical companies; however CROs should be able to advise, fill any
knowledge gaps and conduct required BE studies. This evolution is likely to provide a boost for China’s
CRO industry but it is likely that local CROs will face major hurdles as they attempt to enhance their own
quality processes in order to meet the NMPA’s stricter requirements. Sponsors will be motivated to use
reliable CROs with established standards to manage their trials and generate reliable data to meet
requirements and support approvals.
The reforms will undoubtedly benefit new drug innovators planning to conduct meaningful, scientific trials.
This should ensure that trial site resources are used more effectively on good quality research which will
have a long-term, positive impact for the Chinese pharmaceutical industry. The reforms will have a
profound and lasting impact on China’s pharmaceutical industry. It is likely some of the manufacturers
and their drugs will disappear over the next few years. However, there is a major incentive for innovative
local companies to progress their efforts in new drug development.
More reforms can be anticipated and indeed the Government has already laid out some of the plans for
2019 therefore it is essential that local China regulatory expertise is available to closely monitor these
changes and ensure accurate and timely communication to all relevant stakeholders. In addition, a robust
China regulatory strategy consultation or assessment will need to be prepared and agreed on much
earlier than before in order that Chinese activities can be effectively integrated into the global program
from the start.
80
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On March 30, 2020, State Administration for Market Regulation (SAMR) announces “Regulations on Drug
Registration” and NMPA Announcement on Implementing “Regulations on Drug Registration”, to be
effective on July 1, 2020. The key features are set as below:
The 2020 DRR summarized the experience and stabilize the achievements of the reform of
review and approval system of drugs and medical devices, according to the State Council about
“The opinion on the reform of review and approval system of drugs and medical devices"(guo fa
[2015] 44), and the General office of the central committee of the communist party of China and
General Office of the State Council about "The opinion on deepening the reform of the review and
approval system and encouraging the innovation of drugs and medical devices([2017] no. 42)”.
The 2020 DRR optimize the management process to implement the reform requirements of
"delegating control and service".
In drug registration, through introduction of "60 working days IND review and approval, the drug
evaluation, registration inspection, testing carried out by "parallel" instead of "sequential", and set
start and finish time points and total timeline, further improve the efficiency of the review and the
applicant within the timeline for drug approval is expected.
The 2020 DRR take risk management as the principle, play precision management.
If safety problems or other risks are found during the drug clinical trial, the sponsor shall promptly
adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to CDE;
Changes during clinical trials shall be evaluated for their impact on subject safety risks and shall
be reported in the safety update report during development or supplementary application shall be
submitted.
The 2020 DRR also consider how to maintain stable and highlight management attributes, at a
time new technologies, new production organization methods, new therapeutic and research
ideas are emerging. Therefore, the 2020 DRR is based on frame work and no appendix, while the
flexibility will be reflected in the accompanying guidelines and working procedures.
More than 50 accompanying guidelines and working procedures are planned, so far, there are 30
announced for public consultation. The plan is to be implemented in stages by the end of 2020.
81
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