Volume VI 2015 1

Published byChina Center for Food and Drug International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

CHINA FOOD AND DRUG NEWSLETTER

施维雅(天津）制药有限公司

中国食品药品国际交流中心

Volume2015 6

药品Drug

《中华人民共和国药典》2015年版将全面提升我国药品质量整体水平

2015 Edition of Pharmacopeia of the People’s Republic of China to Enhance the Overall Level of China's Drug Quality

2015年6月5日，国家食品药品监督管理

总局正式颁布《中华人民共和国药典》2015年版（以下简称“新版药典”）。新版药典自12 月1日起实施。新版药典的颁布标志着我国用

药水平、制药水平以及监管水平的全面提升，

将促进药品质量的整体提高，对于保障公众用

药安全有效意义重大。

《中华人民共和国药典》是国家药品标准

的组成部分，是国家药品标准体系的核心。

新版药典进一步扩大药品品种的收载和

修订，共收载品种5608种。一部收载品种2598种，其中新增品种440种。二部收载品种2603种，其中新增品种492种。三部收载品种137种，其中新增品种13种、修订品种105种。首

次将上版药典附录整合为通则，并与药用辅料

单独成卷作为新版药典四部。四部收载通则

总数317个，其中制剂通则38个、检测方法240个、指导原则30个、标准物质和对照品相关

通则9个；药用辅料收载270种，其中新增137种、修订97种。

新版药典的颁布标志着中国的药品标准水

平再上一个新台阶。主要体现在五个方面：一

是新版药典对凡例、通则、总则进行了全面增

修订，整体提升质量控制的要求。二是进一步

扩大了先进、成熟检测技术的应用，重点加强

对药品安全性和有效性的控制要求，药典标准

的科学性、先进性、规范性进一步加强。三是

通过科学遴选品种、提升检测能力、严格限度

规定、完善技术指导原则等措施，使药典的标

准引领作用和技术导向作用显著加强。四是药

用辅料标准的收载品种大幅增加，辅料的质量

控制水平和安全性较大提升。五是完善了药典

标准体系的建设，加强质量全程管理的理念，

强化了《中华人民共和国药典》在国家药品标

准中的核心地位。

（2015-06-18）

On June 5, 2015, China Food and Drug Administration (CFDA) promulgated the 2015 edition of Pharmacopoeia of the People’s Republic of China (hereinafter referred to as "ChP 2015"), which will go into effect on December 1, 2015. The promulgation of the new edition of Chinese Pharmacopoeia marks an overall upgrade in the level of China's drug use, production and supervision. It will drive the overall improvement of drug quality and play a significant role in ensuring drug safety and effectiveness for the public.

T h e C h i n e s e P h a r m a c o p o e i a i s a constituent of the national drug standards, and the core of the national drug standards system.

ChP 2015 further expanded the monographs and revisions of drugs. It covers a total of 5,608 monographs. Volume I contains 2,598 monographs, including 440 new additions. Volume II contains 2,603 monographs, including 492 new additions. Volume III contains 137 monographs, including 13 new additions and 105 revisions. ChP 2015 has for the first time integrated the Appendix of the previous edition into the General Requirements, which, together with the Excipients for Pharmaceutical Use, form a separate Volume IV of ChP 2015. Volume IV contains 317 General Requirements, including 38 General Requirements for preparations, 240 testing methods, 30 Guiding Principles, 9 General Requirements related to standard substance and reference

materials; it also contains 270 monographs of Excipients for Pharmaceutical Use, including 137 new addit ions and 97 revisions.

The promulgation of ChP 2015 marks a new improvement in China's pharmaceutical standards, which is manifested mainly in five aspects: 1. ChP 2015 comprehensively amended and revised the General Notices, General Requirements and General Rules, ra is ing the overal l requirements for quality control. 2. It further expanded the application of advanced & mature testing technologies, and focused on strengthening requirements for the control of drug safety and efficacy, and thereby making the ChP standards more scientific, advanced and standardized. 3. Through scientific selection of monographs, enhancement of testing capacity, setting strictly defined limits, and improving technical guidelines and other measures, the role of the ChP in setting standards and leading technological trends is significantly consolidated. 4. A substantial increase in the monographs of standard Excipients for Pharmaceutical Use will greatly improve the quality control and safety of such Excipients. 5. Improvement in the ChP standards system along with reinforcement of the concept of full-process quality management contributed to consolidate the central role of Chinese Pharmacopoeia in the nat ional drug standards system. (June 18, 2015)

2 CHINA FOOD AND DRUG NEWSLETTER

国家食品药品监督管理总局发布《关于停止生产销售使用酮康唑口服制剂的公告》

CFDA Issues Announcement on Cessation of Production, Distribution & Use of Ketoconazole Oral Formulation

2015年6月25日，国家食品药品监督管

理总局发布《关于停止生产销售使用酮康

唑口服制剂的公告》（2015年第85号）。

根据《中华人民共和国药品管理法》第

四十二条规定，经国家食品药品监督管理总

On June 25, 2015, CFDA issued the Announcement on Cessation of Production, Distribution & Use of Ketoconazole Oral Formulation (No. 85, 2015).

In accordance with Article 42 of the

Drug Administration Law of the People's Republic of China, CFDA concluded after re-evaluation that the risks of Ketoconazole oral formulation outweigh its benefits due to its serious adverse reactions of l iver toxicity. CFDA ordered to stop

国家食品药品监督管理总局公布《药品经营质量管理规范》

CFDA Issues Good Supply Practice for Pharmaceutical ProductsOn May 18, 2015, CFDA promulgated the Good Supply Practice for Pharmaceutical Products (CFDA Order No. 13), which went into effect as of the date of promulgation.

Contents of the Good Supply Practice for Pharmaceutical Products

Chapter I General Provisions

Chapter II Quality management of Drug wholesale

Section 1 Quality Management System

Section 2 Organizational Institution and Quality Management Responsibilities

Section 3 Personnel and Training

Section 4 Quality Management System Documents

Section 5 Facilities and Equipment

Section 6 Calibration and Validation

Section 7 Computer Systems

Section 8 Procurement

Section 9 Receipt and Inspection of

Goods

Section 10 Storage and Preservation

Section 11 Sales

Section 12 Delivery out of Warehouse

Section 13 Transportation and Delivery

Section 14 After-sales Management

Chapter III Quality Management of Drug Retail

Section 1 Quality Management and Responsibilities

Section 2 Personnel Management

Section 3 Documentation

Section 4 Facilities and Equipment

Section 5 Procurement and Acceptance upon Inspection

Section 6 Display and Storage

Section 7 Sales Management

Section 8 After-sales Management

Chapter IV Supplementary Provisions

(July 1, 2015)

2 0 1 5年5月1 8日，国家食品药品监

督管理总局公布《药品经营质量管理规

范》（国家食品药品监督管理总局令第13号）.《药品经营质量管理规范》自公布之

日起施行。

《药品经营质量管理规范》章节目录

第一章　总　则

第二章　药品批发的质量管理

第一节　质量管理体系

第二节　组织机构与质量管理职责

第三节　人员与培训

第四节　质量管理体系文件

第五节　设施与设备

第六节　校准与验证

第七节　计算机系统

第八节　采　购

第九节　收货与验收

第十节　储存与养护

第十一节　销　售

第十二节　出　库

第十三节　运输与配送

第十四节　售后管理

第三章　药品零售的质量管理

第一节　质量管理与职责

第二节　人员管理

第三节　文　件

第四节　设施与设备

第五节　采购与验收

第六节　陈列与储存

第七节　销售管理

第八节　售后管理

第四章　附　则 （2015-07-01）

Volume VI 2015 3

国家食品药品监督管理总局印发《关于对取消和下放行政审批事项加强事中事后监管的意见》

CFDA Issues Opinions on Strengthening the Concurrent & Subsequent Supervision for Cancellation or Delegation of Administrative Approval Items to Lower-Level Governments

为落实《国务院关于规范国务院部门

行政审批行为改进行政审批有关工作的通

知》和李克强总理在全国推进简政放权放

管结合职能转变工作电视电话会议上的讲

话要求，2015年6月9日，国家食品药品监

督管理总局印发《关于对取消和下放行政

审批事项加强事中事后监管的意见》（以

下简称《意见》）。

《意见》对行政审批事项事中事后监

管提出10个方面共28项要求：一是明确取

消和下放的行政审批事项；二是科学依法

简政放权。行政审批制度改革要“于法有

据”，确需事先审批的，严格审批管住管

好，法律法规对审批层级有明确规定的，

不得随意下放，禁止对取消事项继续审批

和变相审批；三是统一规范审批标准。推

行标准化审批，公开各项审批标准，严格

遵照审批标准实施；四是强化承接能力建

设。组织专门审评审批培训，对每个省级

局承接能力进行评估，确保达到有责、有

岗、有人、有手段的“四有”目标。五是

加强日常监督检查。落实日常监管责任，

推进分类重点监管、网格化监管和智能化

监管。六是严厉查处违法行为。加大对重

点违法行为的查处力度，加强投诉举报、

监督抽验、日常监管、案件查办等数据分

析，强化行刑衔接，多措并举严打食品药

品违法犯罪行为。七是严格审批备案和事

后评估。建立并严格执行下放和保留的行

政审批事项备案制度，探索建立第三方事

后评估制度。八是优化行政受理服务。加

强对行政审批受理工作的管理，推行行政

审批事项受理单制度，编制行政审批事项

To implement the Notice of the State Council on Regulating and Improving Administrative Approval Behaviors o f Departments under the State Council, and Premier Li Keqiang's requirements as reflected in his speech at the “National Teleconference on Advancing Streamlining Administration and Delegating More Power to Lower-Level Governments, in Conjunction with the Transformation of Government Functions”, on June 9, 2015, CFDA issued the Opinions on S trengthening the Concurrent & Subsequent Supervison for Cancellation Delegation of Administrative Approval Items to Lower-Level Governments (hereinafter referred to as "Opinions").

The Opinions put forward 28 requirements in 10 aspec t s fo r the concur ren t & subsequent supervision of administrative approval items: 1. Specify the administrative approval items to be cancelled or delegated to lower-level governments. 2. Streamline administration and delegate more power to lower-level governments on a scientific and legal basis. The reform of administrative approval system must be based on laws and regulations. Where prior approval is really necessary, it must be well-managed. Where laws and regulations have clearly defined approval hierarchies, powers must not be delegated at will; continued and covert approval of cancelled items must be prohibited. 3. Standardize approval criteria.

Standardized review & approval shall be implemented, and all the approval standards shall be made public and strictly enforced; 4. Enhance capacity building at local levels. Specialized training for review and approval shall be organized. The review capacity of provincial food and drug administration departments shall be evaluated to ensure that they have the responsibilities, posts, staff, and means required for undertaking the review & approval tasks. 5. Strengthen the routine supervision and inspection. The responsibility of daily supervision shall be assigned to promote classified, prioritized, networked and intelligent supervision. 6. Severely punish illegal acts. The investigation and punishment of illegal activities shall be reinforced, along with the data analysis of complaints and reports, supervision and sample testing, routine supervision, and the investigation & handling of cases. Various administrative and penal measures shall be integrated to crackdown on criminal acts related to food and drugs. 7. Strictly conduct record-filing and post-assessment for review & approval items. A record-filing system shall be established and strictly enforced for delegated and reserved administrative approval items, efforts shall be made to explore the establishment of a third-party post-assessment system. 8. Optimize admin i s t r a t i ve accep t ance s e rv i ce . Measures shall be taken to strengthen the

with immediate effect the production, distribution and use of oral Ketoconazole in China, and withdraw its drug approval number. The recall of oral Ketoconazole already on the market shall be completed by the manufacturers before July 30, 2015, and the recalled products shall be disposed under the supervision of local food and drug administration departments where the manufacturers are located. Overdue

局组织再评价，认为酮康唑口服制剂存在严

重肝毒性不良反应，使用风险大于效益，决

定自即日起停止酮康唑口服制剂在我国的生

产、销售和使用，撤销药品批准文号。已上

市销售的酮康唑口服制剂由生产企业负责召

回，召回工作应于2015年7月30日前全部完

成，召回产品在企业所在地食品药品监督管

理部门监督下销毁。逾期未召回的，一经发

现，将依法严肃处理。 （2015-06-25）

recall, once discovered, shall face serious punishment in accordance with law.

(June 25, 2015)

4 CHINA FOOD AND DRUG NEWSLETTER

国家食品药品监管总局正式上线食品安全抽检信息查询平台

国家食品药品监督管理总局发布《关于医疗器械临床试验备案有关事宜的公告》

CFDA Formally Launches Search Platform for Food Safety Sampling & Testing Information

CFDA Issues Announcement on Matters Pertaining to Record Filing of Clinical Trials of Medical Devices

为进一步落实国家食品药品监督管理

总局《关于食品安全监督抽检及信息发布

工作的意见》要求，方便社会各界查询了

解具体产品信息，国家食品药品监管总局

建立了食品安全监督抽检信息查询平台。

该平台涵盖了国家食品药品监管总局2015年以来公布的抽检信息，并将根据抽检情

况实时更新。广大消费者、生产经营者、

媒体等可以通过平台进行模糊查询，了解

相关产品抽检是否合格，产品标称的生产

企业名称及地址、被抽样单位名称及地

址、产品名称、规格型号、生产日期/批号、不合格样品的不合格项目、检验结果

和标准值等内容。 （2015-06-30）

根据《医疗器械监督管理条例》的规

定，2015年7月3日，国家食品药品监督管

理总局发布《关于医疗器械临床试验备案

有关事宜的公告》（2015年第87号），就

备案有关事宜公告如下：

一、开展医疗器械临床试验，申办

者应当在试验项目经伦理审查通过并与临

To further implement CFDA requirements set forth in the Opinions on Food Safety Monitoring Sampling & Test ing and In format ion Disc losure , and c rea te convenience for all sectors of society to inquire about specific product information, CFDA established an information search platform for food safety monitoring sampling & testing. The platform covers all sampling information released by CFDA since 2015, with real time updates on the latest sampling. Consumers, manufacturers & distributors, and the media, etc. can perform fuzzy search on the platform, to acquire information about test ing

result of relevant product samples; the manufacturer’s name and address labeled on the product; the name and address of the enterprise where samples were taken, the product name, specifications and models, production date/batch number, unqualified items of failed samples, test results and standard values, etc. (June 30, 2015)

management of administrative acceptance of review & approval items, including adopting the Acceptance Forms, compiling service guide for administrative review & approval, and strengthening supervision and inspection of entrusted items. 9. Promote informat ion disclosure . Informat ion related to administrative approval shall be disclosed, and the notification system for administrative law enforcement shall be actively implemented. 10. Enforce accountability mechanism by law and discipline. Oversight on supervisory staff shall be tightened; regulators at higher levels shall strengthen supervision on their subordinate departments; and special law

enforcement programs shall be conducted for supervision and inspection.

The Opinions requires that food and drug administration departments at all levels shall, with a view to national public security, effectively strengthen food and drug safety supervision, and speed up the establishment of a scientific and sound food and drug safety management system by implementing “the strictest standards, the most stringent regulation, the most severe punishment, and the most serious accountability”, in an effort to secure each line of defense from farm to table, from laboratory to hospital, and ensure food and drug safety for the public. (June 11, 2015)

食品Food

医疗器械Medical Devices

服务指南，加强对委托受理事项的监督检

查。九是深化监管信息公开。公开行政审

批各项信息，积极推行行政执法公示制

度。十是依法依纪严肃问责。加强对日常

监管人员的监督，加强上级部门对下级的

层级监督，开展专项执法监督检查。

《意见》要求，各级食品药品监督管

理部门从国家公共安全的高度，切实加强

食品药品安全监管，用最严谨的标准、最

严格的监管、最严厉的处罚、最严肃的问

责，加快建立科学完善的食品药品安全治

理体系，严把从农田到餐桌、从实验室到

医院的每一道防线，确保广大人民群众饮

食用药安全。 （2015-06-11）

Pursuant to provisions of the Regulations on Supervision and Administration of Medical Devices, on July 3, 2015, CFDA issued the Announcement on Matters Pertaining to Record Filing of Clinical Trials of Medical Devices (No. 87, 2015), providing the following notices on medical device filing:

1. In order to carry out clinical trial for a

medical device, the applicant shall fill out a Record Filing Form for Clinical Trials of Medical Devices after the trial passes the ethical review and an agreement or contract is signed with the clinical trial institution; the applicant shall then submit the relevant materials listed on the form for filing to the provincial food

Volume VI 2015 5

国家食品药品监督管理总局行政事项受理服务和投诉举报中心调整注册申报资料接收方式

CFDACCR Adjusts Method for Acceptance of Registration Dossiers

为加强与申请人的沟通，提高行政受理

工作效率和质量，国家食品药品监督管理总

局行政事项受理服务和投诉举报中心决定自

2015年7月6日起，调整受理大厅申报资料接收

方式。7月1日，发布《调整注册申报资料接收

方式的公告》（第150号），有关事项如下：

一、进口第一类医疗器械（含体外诊断

试剂）备案、医疗器械（含体外诊断试剂）

登记事项变更申请，依法规要求在受理大厅

窗口现场办理。

二、除进口第一类医疗器械（含体外

诊断试剂）备案、医疗器械（含体外诊断试

剂）登记事项变更申请以外，其他申请事项

一次递交不超过两项的，原则上在受理大厅

现场办理。一次递交超过两项申请事项或申

To better communicate with the applicants and improve the efficiency and quality of administrative services, CFDA Center for Administrative Services and Complaints & Reports (CFDACCR) decided that: as of July 6, 2015, the method for acceptance of registration dossiers shall be adjusted.

On July 1, the Announcement for Adjusting the Method for Acceptance of Registration Dossiers (No. 150) was released, stating the following matters:

1. In accordance with the regulatory requirements, filing for imported Class I medical devices (incl. IVDs) and application for alteration of registered items for medical devices (incl. IVDs) shall be accepted on-site at the CCR service windows.

2. Aside from filing for imported Class I medical devices (incl. IVDs) and application for alteration of registered

床试验机构签订协议或合同后，填写《医

疗器械临床试验备案表》，提交备案表中

列出的相关材料，其中境内医疗器械向申

办者所在地省级食品药品监督管理部门备

案，进口医疗器械向代理人所在地省级食

品药品监督管理部门备案。 二、接受备案的省级食品药品监督

管理部门，对《医疗器械临床试验备案

表》填写完整且提交材料齐全的，应当当

场备案。备案号编排方式为：X1械临备

XXXX2XXXX3，其中X1为备案部门所在

地简称，XXXX2为年份，XXXX3为流水

号。

三、接受备案的省级食品药品监督管

理部门，应当在10个工作日内将备案信息

通报临床试验机构所在地的同级食品药品

监督管理部门和卫生计生主管部门。 四、自公告发布之日起，开展医疗器

械临床试验应当按照本公告备案后实施。

五、申办者完成临床试验备案后，对

试验项目起止日期有变化的，应当于变化

后10个工作日内告知原备案管理部门并留

有信息变更的记录。

六、食品药品监督管理部门应当加

强对医疗器械临床试验备案工作的监督检

查，对违反规定的依法查处。

接受备案的省级食品药品监督管理部

门应当每月10日前将备案信息以电子邮件

方式报送国家食品药品监督管理总局医疗

器械注册管理司。 （2015-07-03）

and drug supervision and administration department where the applicant is located. Clinical trial of an imported medical device shall be filed to the provincial food and drug supervision and administration department where its agent is located.

2. Where the applicant has filled out the Record Filing Form for Clinical Trials of Medical Devices and submitted all the required materials, the provincial food and drug regulatory department shall accept and process the filing on the spot. A filing number shall be issued to the filed records, which reads as “X1medical device clinical trial filing XXXX2XXXX3” wherein X1 is the abbreviated name for the province where the filing department is located; XXXX2 is the year of filing; and XXXX3 is the serial number.

3. The provincial food and drug regulatory department that accepts the filing shall, within 10 working days, notify the food and drug regulatory department and the competent health and family planning authority at the same level where the clinical trial institution is located that the clinical trial has been filed.

4. Starting from the date of issuance of this

Announcement, clinical trials of medical devices shall be filed in compliance with the Announcement before being conducted.

5. Where a change is made to the start and end dates of a clinical trial that has already been filed, the applicant shall notify the original filing department of the change within 10 working days and keep a record of the change in the filing information.

6. Food and drug regulatory departments s h o u l d e n h a n c e s u p e r v i s i o n a n d inspection of clinical trial record filing for medical devices and investigate and punish violations in accordance with law.

The provincial food and drug supervision and administration department that accepts the filing of a medical device clinical trial should report the filing information to the Department of Medical Device Registration at CFDA via email before the 10th day of each month. (July 3, 2015)

6 CHINA FOOD AND DRUG NEWSLETTER

国家卫生和计划生育委员会发布《关于落实完善公立医院药品集中采购工作指导意见的通知》

National Health and Family Planning Commission Issues Notice on Implementing the Guidance on Improving Centralized Drug Procurement in Public Hospitals

为贯彻落实《国务院办公厅关于完善公

立医院药品集中采购工作的指导意见》（国

办发〔2015〕7号，以下简称《意见》），

2015年6月11日，国家卫生和计划生育委员

会发布《关于落实完善公立医院药品集中

采购工作指导意见的通知》（国卫药政发

〔2015〕70号），就全面构建药品集中采

购新机制二、合理确定药品采购范围、细

化药品分类采购措施、坚持双信封招标制

度、改进医院药款结算管理、完善药品供

应配送管理、加快推进采购平台规范化建

设、规范医院药品使用管理、加强公立医

院改革试点城市药品采购指导、 加强综合

监管、加大宣传培训进行了通知。 （摘自：国家卫生和计划生育委员会网

站 2015-06-11）

To implement the Guidance of the General Office of the State Council on Improving Centralized Drug Procurement in Public Hospitals (SC General Office [2015] No. 7, hereinafter referred to as the “Guidance”), on June 11, 2015, the National Health and Family Planning Commission issued the Notice on Implementing the Guidance on Improving Centralized Drug Procurement in Public Hospitals (NHFPC Department of Drug Policy and Essential Medicine [2015] No . 70) , no t i fy ing a l i s t o f requirements including: establishing new mechanism for centralized procurement of drugs; setting reasonable scope for drug

procurement; making detailed measures for classified drug procurement; adhering to the two-envelope tender system; improving account ing management a t hospi ta l pharmacies; improving drug supply and distribution management; accelerating s tandard iza t ion of the procurement platform; regulating hospital drug use management; enhancing the guidance for drug procurement in pilot cities of public hospital reform, strengthening comprehensive supervision, and reinforcing publicity campaign and training.

(From: NHFPC website, June 11, 2015)

综合信息General Information

国家食品药品监督管理总局办公厅发布《关于恒温核酸扩增检测仪等22个产品分类界定的通知》

CFDA General Office Issues Notice on the Classification of 22 Products Including Diagnostic Devices for Isothermal Nucleic Acid Amplification

为适应医疗器械监督管理工作的需

要，国家食品药品监督管理总局组织有关

单位和专家对恒温核酸扩增检测仪等22个产品的管理类别进行了界定。2015年6月11日发布界定通知，作为Ⅲ类医疗器械管理

的产品1个；作为Ⅱ类医疗器械管理的产品

7个；作为第Ⅰ类医疗器械管理的产品13个；不按照医疗器械管理的产品1个。

通知要求，自通知发布之日起，对

于不作为医疗器械管理的，如已受理尚未

完成注册审批的，食品药品监管部门应按

规定不予注册，相关注册申请资料予以存

档。尚在有效期内的医疗器械注册证书不

得继续使用。 （2015-06-11）

To meet the demands of medical device r e g u l a t i o n , C h i n a F o o d a n d D r u g Administration (CFDA) organized relevant institutions and experts to determine the classifications of 172 products including diagnostic devices for isothermal nucleic acid amplification. The classification notice was issued on June 11, 2015, which lists 1 product as Class III medical device, 7 products as Class II medical devices, 13 products as Class I medical devices, and 1 product not classified as medical device.

The Notice requires that, upon its issuance, for products not classified as medical

devices, the food and drug regulatory depar tments shal l not approve their registration applications that have been submitted and shall keep the relevant application materials for records; if such products have already been registered, their registration certificates that are still within the term of validity shall be discontinued for use. (June 11, 2015)

报资料相对复杂，受理人员在窗口短时间无

法决定的申请事项，均采用签收方式接收申

报资料。

三、鼓励申请人优先选择在受理大厅签

收窗口签收或邮寄方式办理行政许可申请业

务。 （ 2015-07-01）

items for medical devices (incl. IVDs), other applications with no more than two items to file at a time shall, in principle, be accepted on-site at the CCR Hall. For applications with more than two items to file at a time, or relatively complex dossiers that cannot be determined by the

service staff on site within a short time, the dossiers shall be accepted upon sign-in for further consideration.

Applicants are encouraged to choose the method of receipt by sign-in at the lobby windows or by mail when applying for administrative licensing. (July 1, 2015)

Volume VI 2015 7

2015年1至4月医药外贸情况

Overview of Pharmaceutical Foreign Trade from January to April 2015

Special Focus 业界专题

2015年1至4月，我国进出口额325.87亿美元，同比增长6.9%，预计全年出口增幅

7%左右。

总体保持稳步增长

1至4月，医药对外贸易保持稳定增

长态势，进出口额325.87亿美元，同比增

长6.9%。其中，出口184.3亿美元，增长

7.4%；进口141.6亿美元，增长6.2%，对外

贸易顺差42.7亿美元，同比增长11.4%。

中药类：植提物30%增幅亮眼

按产品类别来看，中药类产品中，植

物提取物以7.20亿美元的出口额， 30%以上

的增幅引领中药类产品出口。大部分中药

材及饮片产品价格呈下跌趋势， 尤其受日

元贬值影响，第一大市场日本的出口额下

跌23%。

西药类：制剂出口增速加快

西药类产品出口保持较稳定的增长，

西药原料药出口从去年二季度开始止跌企

稳，出口增幅一直维持在3%～5%左右，

但是部分大类产品如解热镇痛类产品、维

生素类产品量价齐跌。制剂出口10.32亿美

元，同比增长13.6%，出口增速加快。内资

出口企业排名前20的企业中有14家制剂出

口增速超20%。

器械类：均衡持久发展

器械类产品出口增长稳定。1～4月，

我医疗器械出口额64.9亿美元，同比增长

9.51%。低端产品医用敷料、一次性耗材，

中高端产品医院诊断与治疗设备出口额均

有不同程度的增长。转型升级的拉动、

结构调整的平衡使得我国器械出口产品层

级更加合理，更趋于均衡、持久的发展趋

势。

（摘自：医药经济报 2015-06-18）

From January to April 2015, China's import and export volume hit $32.587 billion, up by 6.9% YOY. The annual export growth is expected to be around 7%.

Steady overall growth

F r o m J a n u a r y t o A p r i l 2 0 1 5 , pharmaceutical foreign trade maintained a stable growth. The import and export volume totaled $32.587 billion, up by 6.9% YOY. During this period, exports grew by 7.4%, reaching $18.43 billion; while imports grew by 6.2%, reaching $14.16 billion, creating a surplus of $ 4.27 billion, which was up by 11.4% YOY.

TCM: plant extract export achieved a startling growth of 30%

Plant extracts brought in $720 million in export and took the lead in all categories of TCM products with a growth rate of over 30%. Most Chinese crude drugs and the prepared slices of Chinese crude drugs showed a downward slide in prices; particularly, affected by the depreciation of the Japanese Yen, exports to the largest export market, Japan, dropped by 23%.

Western medicine: growth in export of preparations accelerated

Export of Western medicine products maintained a relatively steady growth.

API export has stabilized since the second quarter of last year, keeping the growth rate at around 3% to 5%. By contrast, there has been a drop in both the volume and price of export for some major product categories, such as antipyretic-analgesic products and vitamin products. Growth in the expor t o f Wes te rn preparations has accelerated, with its volume reaching $1.032 billion from January to April this year, up by 13.6% YOY. Of the top 20 domestic export enterprises, 14 have a growth rate of over 20% in preparations export.

M e d i c a l d e v i c e s : b a l a n c e d & sustainable development

Medical device products enjoyed a stable export growth. From January to April, China's medical device exports hit $6.49 billion, up by 9.51% YOY. Export of both low-end products (incl. medical dressings, disposable supplies) and medium & high-end products (incl. hospital diagnostic & treatment equipment) witnessed varying degrees of growth. The impetus in the wake of transformation and upgrading and the balance as a result of restructuring and adjustment have rendered a more reasonable product hierarchy and a more balanced & sustainable development trend for the export of medical devices.

(From: Medicine Economic Reporter, June 18, 2015)

8 CHINA FOOD AND DRUG NEWSLETTER

China Center for Food and Drug International Exchange (CCFDIE)中国食品药品国际交流中心

Address: Room 1106, 11th Floor, Office Building B, Maples International Center, No. 32, Xizhimen North Street, Haidian District, Beijing, 100082, P.R.C.

中国北京市海淀区西直门北大街32号枫蓝国际中心B座写字楼11层1106室邮编：100082

Tel: 010-8221 2866 Fax: 010-8221 2857Email: ccpie@ccpie.orgWebsite: www.ccpie.org

Servier (Tianjin) Pharmaceutical Co., Ltd.施维雅（天津）制药有限公司

Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, 100020 Beijing, China

北京市朝阳区东三环中路1号环球金融中心西楼6层 邮政编码：100020

Tel: 010-6561 0341Fax: 010-6561 0348E-mail: Linda.zhang@cn.netgrs.comWebsite: www.servier.com.cn

Notes: • All Chinese information in the Newsletter is extracted from newspapers and the Internet. All English articles are translations from the Chinese version.

• For electronic version of the Newsletter please visit http://www.ccpie.org 备 注： • Newsletter中所有中文信息摘自报刊及网络。英文均系中文翻译。

• 电子版Newsletter阅览请登录网站http://www.ccpie.org