annual report - npra.gov.my · between medicine regulators globally is visible now more than ever....

NATIONAL PHARMACEUTICAL REGULATORY AGENCYBAHAGIAN REGULATORI FARMASI NEGARA

36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.Tel : +603-7883 5400 Faks : +603-7956 2924

ANNUAL REPORTLAPORAN TAHUNAN

ANNUAL REPORT

B A H A G I A N R E G U L A T O R I F A R M A S I N E G A R AN A T I O N A L P H A R M A C E U T I C A L R E G U L A T O R Y A G E N C Y

NATIONAL PHARMACEUTICAL CONTROL BUREAU

TABLE OF CONTENTVision, Mission, Objective

Director’s Foreword

Top Management

Introduction

Organisation Chart

Client Charter

Statistics

Highlights & Activities

Latest Information

International Collaboration & Participation

Publications

Financial Report

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17212627

VISION, MISION,OBJECTIVE

To ensure the therapeutic substances approved for the local market are safe, effective & of quality and also to ensure that cosmetic products approved are safe and of quality.

To be an internat ional ly renowned regulatory authority for medicinal products and cosmetics.

To safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

OBJECTIVE

VISION

MISION

1NATIONAL PHARMACEUTICAL CONTROL BUREAU NATIONAL PHARMACEUTICAL CONTROL BUREAU

VISION, MISION,OBJECTIVE

To ensure the therapeutic substances approved for the local market are safe, effective & of quality and also to ensure that cosmetic products approved are safe and of quality.

To be an internat ional ly renowned regulatory authority for medicinal products and cosmetics.

To safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

OBJECTIVE

VISION

MISION

2017ANNUAL REPORT

2NATIONAL PHARMACEUTICAL CONTROL BUREAU

Dr. Ramli ZainalDirector

Noorul Akmar Mohd. NurDeputy Director of

Centre for Quality Control

Muhammad Lukmani IbrahimDeputy Director of Centre for Compliance

and Licensing

Siti Aida AbdullahDeputy Director of

Centre for Organisational Development & Strategic Planning

Dr. Noraida Mohamad ZainoorDeputy Director of

Centre for Investigational New Products

Faridah Iryani Md. YusofDeputy Director of Centre for Product

Registration

Othman AhmadHead of Centre for

Administration

Wan Mohaina Wan MohammadDeputy Director of

Centre for Post Registration of Products& Cosmetic Control

As we move forward in this ever changing and challenging field of disease prevention and

cure, medicines regulation is utmost important. Responding to the World Health Assembly’s call for the strengthening of regulatory systems worldwide, the search for a common ground between medicine regulators global ly is visible now more than ever. Convergence has become a common topic of interest between regulators. NPRA believes the first step to this is understanding each other’s regulations and practices through capacity building and information sharing.

This year NPRA has successfully organised the training programme entitled Pharmaceutical Regulatory System Training Programme focus-ing on Regulation of Biologics. Twelve partici-pants from ten countries attended this 5-day programme and feedback from the participants were encouraging. This is the third training pro-gramme we’ve conducted since 2013, where the past two focused on Regulation of Phar-maceuticals. We strive to continue this effort in the years to come to reach more regulators worldwide.

Apart from continuously being an active WHO Collaborating Centre for Regulatory Control of Pharmaceuticals by providing on-going hands-on training for WHO Member States, NPRA is delighted to have co-hosted the 6th Global Vac-

Director’s forewordDR. RAMLI ZAINAL

cines Safety Initiative (GVSI) alongside WHO in October this year. A total of 96 participants from 24 countries including WHO representatives at-tended this meeting which serves as a platform for Member States and partners to interact and exchange information on vaccine pharmacovig-ilance activities.

Apart from strengthening regulatory control to ensure the quality, efficacy and safety of registered products in the country, NPRA also continued to participate in the realization of one of the government’s vision to improve the liveli-hood of its citizens in the rural areas through our involvement in the Rural Transformation Centre (RTC) project. NPRA conducted two seminars in 2017 targeting the local traditional and cos-metics manufacturers. Assisting the local man-ufacturers is important to NPRA as we show our support to locally manufactured products which will directly boost the economy.

NPRA will continue to move alongside its region-al and international counterparts to strengthen the regulatory control of medicines, health supplements, traditional products as well as cosmetics to ensure the public’s safety. This is not an easy task, but with the focus and com-mitment from each NPRA staff while carrying out their daily work as well as striving to give the best service to the public, I am sure we can achieve our mission.


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Dr. Ramli ZainalDirector

Noorul Akmar Mohd. NurDeputy Director of

Centre for Quality Control

Muhammad Lukmani IbrahimDeputy Director of Centre for Compliance

and Licensing

Siti Aida AbdullahDeputy Director of

Centre for Organisational Development & Strategic Planning

Dr. Noraida Mohamad ZainoorDeputy Director of

Centre for Investigational New Products

Faridah Iryani Md. YusofDeputy Director of Centre for Product

Registration

Othman AhmadHead of Centre for

Administration

Wan Mohaina Wan MohammadDeputy Director of

Centre for Post Registration of Products& Cosmetic Control

TOP MANAGEMENT

3 NATIONAL PHARMACEUTICAL CONTROL BUREAU

2017ANNUAL REPORT


National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National

Pharmaceutical Control Laboratory, was set up in October 1978. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities.

Starting from 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through evaluation of scientific data and laboratory tests. A system to monitor products in the market was also established. Over the years, NPRA has extended the control of the quality and safety of non-prescription medicines, traditional products, cosmetics, veterinary products, active pharmaceutical ingredients (API) including the quality control of vaccine through Vaccine Lot Release activities which started this year.

In view of its technical expertise and training capabilities, NPRA was given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. This recognition has attracted foreign regulatory agencies

INTRODUCTION

to undergo training in NPRA. Apart from that, this recognition has placed NPRA on an international platform and enhanced cooperation between NPRA and other international regulatory agencies.

In addition to that, NPRA has successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPRA has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

NPRA is constantly striving towards upgrading its Quality Management System. NPRA has successfully obtained the MS ISO 9001:2015 certification from SIRIM as well as the MS ISO 17025:2005 accreditations for Centre for Quality Contro, NPRAl under the Malaysian Laboratory Accreditation Scheme (SAMM).

Since its establ ishment, NPRA has gone through a series of transformation to advance itself as a regulator and to be on par with international counterparts. With the commitment and dedication of all NPRA staff, NPRA is well equipped to overcome future challenges and will continue to ensure that the medicines in the market are safe, of good quality and efficacious for public consumptions.

DIRECTOR

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DIRECTOR

Centre for Investigational New Product• Conduct inspections on clinical trial

sites • Conduct inspections on

Bioequivalence centres • Issuance of import license to import

drugs for clinical trials as well as exemptions for manufacturer of products for this purpose

Centre for Post Registration of Products & Cosmetic Control• Post registration surveillance

activities• Pharmacovigilance• Cosmetic Notifications

Centre for Compliance and Licensing• Inspection on manufacturing sites • Issuance of manufacturers,

importers and wholesalers licenses

Centre for Organisational Development and Strategic Planning• Manages the on-line registration

system (QUEST system) and NPCB’s official website

• Coordinate training activities • The Helpdesk unit handles inquiries

Centre for Administration• Administrative and financial tasks

Centre for Product Registration• Dossier evaluation for product

registration

Centre for Quality Control• Chemical & microbiological testing• Analytical validation data evaluation• Validation of new testing methods

Organisation Chart2017ANNUAL REPORT


CLIENT CHARTERPRODUCT REGISTRATION DURATION

Full Evaluation

• To evaluate application for registration of:o Prescription drugs o Non-prescription drugso New drugs and biological

210 working days*210 working days*245 working days*

Abridged Evaluation

• To evalute application for registration of non-prescription medicine#, health supplements and traditional products containing:o Single active ingrediento 2 or more active ingredients

• Issuance of cosmetic notification• Certificate of Free Sale for Cosmetic Products• Change of registration holder • Certificate of Pharmaceutical Product (CPP)/Certificate of Free Sale (CFS)• Change of manufacturing site application

116 working days*136 working days*

1 working day^15 working days*45 working days*15 working days*60 working days*

LICENSING DURATION

• Issuance of manufacturer’s, wholesaler’s and importer’s license• Evaluation of import license application for Clinical Trial License (CTIL) and

Clinical Trial Exemption (CTX):o For products involving Phase 1 Trial, biological products, Cell & Gene

Therapy Products (CGTPs) and herbal productso For products other than stated above

4 working days*

45 working days*

30 working days*

*Upon receipt of complete application^For applications fulfilling the stipulated requirements# For products that are listed in Table V of the Drug Registration Guidance Document (DRGD)

2017ANNUAL REPORT


Number of Product Registration Application Received

Prescription

Non-Prescription Natural

HealthSupplement

191

61 807 280Number of Product Registered

Prescription NaturalHealth

Supplement Veterinary

325 651 242 68Number of NewCosmetic ProductNotification Application

107419

Number of Licenses Issued

Number ofADR/AEFIReportReceived

15936Number ofproductssampledfrom themarket

3930Number of product tested

3317

PENYELIDIKANPENYELIDIKAN

Manufacturer License

Importer License

Wholesaler License

Clinical Trial Import License

Clinical Trial Exemption

3044641110276

27

Non-Prescription

61

Veterinary

64

STATISTICS2017ANNUAL REPORT


Number of Good ManufacturingPractice (GMP) Inspections

433

Number of Good Distribution Practice (GDP)Inspections

133

Number of application for Lot Release

Number of Clinical Trial Site Inspections10

Number of Inspections onBioequivalence Centre (BE) 26

Number of queries andcomplaints solved 14124

Number ofdialogues carriedout with the localindustry

8

Number of visitors to NPRA

Local

International

258

51

Vaccine

281

Plasma

123

2017ANNUAL REPORT


2017 HIGHLIGHTS & ACTIVITIES


Pharmaceutical Regulatory System for Biologics

Training Programme on

The National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia successfully organised the Training Programme on Pharmaceutical Regulatory System for Biologics for officers from regulatory agencies / government bodies of identified countries on 25 – 29 September 2017 at NPRA. A total of 12 participants from 10 countries attended the said programme (United Republic of Tanzania, Republic of Uzbekistan, Nigeria, Thailand, Jordan, Sudan, Indonesia, Iran, Kazakhstan, Morocco).

The objectives of this training include:üIntroduce officers from identified regulatory

agencies / government bodies to the regulatory system in Malaysia which is advanced and in line with international pharmaceutical / biological regulatory requirements.

üI l lustrate NPRA’s commitment to i ts responsibility in ensuring biologic therapeutic products marketed are safe, of quality and effective.

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Sixth Global Vaccine Safety Initiative Meeting

The World Health Organizat ion (WHO) in collaboration with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia and ASEAN successful ly organised the Sixth Global Vaccine Safety

Expected Outcomes

Successful approaches to monitor adverse event following immunization identified

Needs and opportunities to support countries in implementing an effective vaccine pharmacovigilance system identified

Collaborative mechanisms and partnerships within the GVSI and with regional regulatory harmonization initiatives established and strengthened

Initiative (GVSI) Meeting on 11 – 12 October 2017 in Malaysia. A total of 96 participants from 24 countries including WHO representatives attended this meeting which serves as a platform for Member States and partners to interact and exchange information on vaccine pharmacovigilance activities.

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RTC Seminar on the Control of Traditional Registered Medicines and Notified Cosmetics 2017

A total of two RTC Seminars were conducted throughout 2017. The Central Zone RTC Seminar was held on 25 and 26 April 2017 at Dewan Anggerik, National Pharmaceutical Regulatory Agency (NPRA), Petaling Jaya, Selangor whereas the Sarawak Zone RTC Seminar was held on 30 and 31 October 2017 at UTC Kuching, Sarawak.

The Central Zone RTC Seminar was attended by a total of 102 participants which comprised of

members of the public as well as manufacturers of registered traditional products and notified cosmetics. The Sarawak Zone RTC Seminar was attended by a total of 29 participants which comprised of the public, pharmacists from the Sarawak Pharmacy Enforcement Division as well as manufacturers of registered traditional product and notified cosmetics.

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2017 LATEST INFORMATION


ON-LINE SYSTEM

The National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia officially launched the upgraded on-line registration system i.e. QUEST3+ in January 2017.

Additional features on QUEST 3+ include four new modules including membership registration module, helpdesk module, admin module and

cosmetic notification module. QUEST3 + also offers online payment services.

NPRA also launched the on-line ADR reporting system in 2017. NPRA will continue to strive towards increasing the quantity and quality of ADR reports received in Malaysia. An on-line reporting system specifically for consumers has also been established, and is known as the ConSERF Online.

2017ANNUAL REPORT


DEVELOPMENT OF THE MALAYSIAN HERBAL MONOGRAPH

Melada pahit (Buah)Brucea javanica (L.) Merr. (Fruit)

Pinang (Biji)Areca catechu (L.) (Seed)

The Malaysian Herbal Monograph (MHM) is a crucial reference to establish good quality of raw material herbs for herbal or traditional products. It is identified as one of the entry point projects (EPP) under the National Key Economic Areas (NKEA). The monograph provides valuable information such as identification of herbs, quality control requirements, medicinal usage and safety information. This is to ensure production of local traditional products is safe, of high quality, competitive and comply with international standards.

The role of the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia via its Centre for Quality Control in the development of the Malaysian Herbal Monograph includes:

a) Collaborate with other organisations to conduct training / workshops / seminars for the local traditional industry as well as the MHM team.

b) Verification testing on herbal raw materialsc) Development and improvement of testing

methodologiesd) Development of new monograph for Lignosus

rhinocerus.e) Act as Secretariat and member of MHM

Technical Committee

In 2017, a total of 10 Herbal Monographs have been developed under the NKEA project, namely:

1) Petai (Biji) - Parkia speciosa Hassk. (Seed)2) Tunjuk langit (Biji) - Swietenia macrophylla King

(Seed)3) Pokok kapal terbang (Daun) - Chromolaena

odorata (L.) R.M. King& H. Robinson (Leaf)4) Pinang (Biji) - Areca catechu (L.) (Seed)5) Melada pahit (Buah) - Brucea javanica (L.) Merr.

(Fruit)6) Lengkuas (Rizom) - Alpinia galanga (L.) Willd.

(Rhizome)7) K a c i p f a t i m a h ( A k a r )

- M a r a n t o d e s p u m i l u m ( B l u m e Kuntzevar. Pumila (Roots)

8) K a c i p f a t i m a h ( D a u n ) - M a r a n t o d e s p u m i l u m ( B l u m e ) Kuntzevar. Pumila (Leaves)

9) Ara tanah (Aerial) - Euphorbia hirta L. (Aerial)10) Daun salam (Daun) - Syzygium polyanthum

(Wight.) Walp. (Leaf)

The herbal monograph can be accessed for free via http://www.globinmed.com/.

2017ANNUAL REPORT

http://www.globinmed.com/


Pokok kapal terbang (Daun)Chromolaena odorata (L.) R.M.

King & H. Robinson (Leaf)

Tunjuk langit (Biji)Swietenia macrophylla King

(Seed)

Petai (Biji)Parkia speciosa Hassk. (Seed)

Kacip fatimah (Akar)Marantodes pumilum (Blume)

Kuntzevar. Pumila (Roots)

Ara tanah (Aerial)Euphorbia hirta L. (Aerial)

Daun salam (Daun)Syzygium polyanthum (Wight.)

Walp. (Leaf)

Kacip fatimah (Daun)Marantodes pumilum (Blume)

Kuntzevar. Pumila (Leaves)

Lengkuas (Rizom)Alpinia galanga (L.) Willd.

(Rhizome)

2017

2017ANNUAL REPORT


2017INTERNATIONAL

COLLABORATIONS & PARTICIPATIONS


Technical Bilateral Meetings

(a) 6th Technical Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia

The 6th Technical Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia and Health Sciences Authority (HSA), Singapore was held on 24 August 2017 at the NPRA’s premises in Petaling Jaya, Selangor. The Malaysian delegation was headed by YBhg. Dr. Salmah Bahri, Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, whereas the Singapore delegation was led by Dr. Mimi Choong May Ling, Chief Executive Officer of HSA Singapore.

The meeting discussed regulatory updates from both agencies as well as the continuous collaboration between the two agencies in various fields including the on-going parallel review activity as well as the post-registration development of the dengue vaccines in both countries.

(b) Technical Meeting between the National Pharmaceutical Regulatory Agency (NPRA) and the Pharmaceutical and Medical Device Agency (PMDA) Japan

A technical meeting between the National P h a rm a c e u t i c a l Re g u l a t o r y Ag e n c y (NPRA), Ministry of Health Malaysia and the Pharmaceutical and Medical Device Agency (PMDA) Japan was held on 4 April 2017 in Tokyo, Japan. The meeting discussed future cooperation between the two agencies. YBhg. Dr. Salmah Bahri, Senior Director of Pharmaceutical Services, Malaysia together with Mdm. Siti Aida Abdullah, the Deputy Director of Centre for Strategic Planning & Development from the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia attended the meeting.

(c) 6th Bilateral Technical Working Group Malaysia - Brunei Pharmaceutical Care and Regulatory System (via video conference)

A video conference session was held on 2 March 2017 in conjunction with the 6th Bilateral Technical Working Group Malaysia - Brunei Pharmaceutical Care and Regulatory System. The meeting discussed areas of cooperation in the field of inspection & licensing, testing method validation of traditional medicines & cosmetic products as well as Halal Pharmaceutical Standards.

NPRA’s Participation in ASEAN Working Groups

The ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 to facilitate the accomplishment of the objectives of the ASEAN Free Trade Agreement. In 2004, the ACCSQ was tasked to undertake activities in relation to the establishment of an ASEAN Economic Community (AEC).

Launched in 2015, the AEC aims to eventually create a single market and production base within ASEAN countries. This will allow for the

2017ANNUAL REPORT


free movement of goods, services, skilled labour and investment among the 10 ASEAN member nations, and facilitate the free flow of capital. Harmonisation of technical regulations and mutual recognition agreements (MRA) are among the strategies that will be adopted by the AEC to reduce trade costs.

Through the National Pharmaceutical Regulatory Agency (NPRA), Malaysia actively participates in

three product working groups which aim to develop harmonisation schemes of pharmaceuticals, traditional medicines and health supplements as well as cosmetics regulations in ASEAN countries. There are three working groups under the ACCSQ – the Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) and the ASEAN Cosmetic Committee (ACC).

Below are the ASEAN meetings attended by NPRA officers in the year 2017:

Bil.No.

MesyuaratMeeting

Tarikh Date

TempatVenue

1.Workshop on Implementation of Mutual Recognition Arrangement of Bioequivalence Study Reports of Generic Medicinal Products

22 – 23 February 2017 Kuala Lumpur

2.ASEAN Trad i t iona l Medic ines and Health Supplements Good Manufacturing Practice Training of Trainer Workshop

21 – 23 March 2017 Selangor

3. 9th ASEAN Cosmetic Testing Laboratory Committee (ACTLC) Meeting 1 – 4 May 2017 Cambodia

4. 26th ASEAN Cosmetic Committee (ACC) & 27th ASEAN Cosmetic Scientific Body (ACSB) meetings 1 – 5 May 2017 Siam Reap, Cambodia

5.24th Meeting of Traditional Medicines and Health Supplements (TMHS) Good Manufacturing Practice (GMP) Task Force

16 – 17 May 2017 Da Nang, Viet Nam

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Bil.No.

MesyuaratMeeting

Tarikh Date

TempatVenue

6.31st ASEAN Technical Scientific Committee (ATSC) Meeting for Traditional Medicines and Health Supplements (TMHS)

17 May 2017 Da Nang, Viet Nam

7.

27th Meeting of the ASEAN Consultative Committee for Standards and Quality on Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG) Meeting

18 – 19 May 2017 Da Nang, Viet Nam

8.

Joint Assessment Coordinating Group of ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group Meeting with the World Health Organization and ASEAN Drug Regulatory Authorities

11 – 12 July 2017 Kuala Lumpur

9. 13th Meeting of Task Force on BA/BE ACCSQ Pharmaceutical Product Working Group (PPWG) 24 – 25 July 2017 Bangkok, Thailand

10. 24th Meeting of the ACCSQ Pharmaceutical Product Working Group 24 – 28 July 2017 Bangkok, Thailand

11.25th Meeting of Traditional Medicines and Health Supplements (TMHS) Good Manufacturing Practice (GMP) Task Force

24 – 25 October 2017 Brunei Darussalam

12.32nd ASEAN Technical Scientific Committee (ATSC) Meeting for Traditional Medicines and Health Supplements (TMHS)

25 October 2017 Brunei Darussalam

13.

28th Meeting of the ASEAN Consultative Committee for Standards and Quality on Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG Meeting)

26 – 27 October 2017 Brunei Darussalam

14. 27th ASEAN Cosmetic Committee (ACC) & 27th ASEAN Cosmetic Scientific Body (ACSB) meetings 14 – 17 November 2017 Bandung, Indonesia

15. 10th ASEAN Cosmetic Testing Laboratory Committee (ACTLC) Meeting 14 – 17 November 2017 Bandung, Indonesia

16. Special Head of Delegates Meeting ACCSQ PPWG 29 – 30 November 2017 Singapore

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The NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognit ion is an a c k n o w l e d g e m e n t f r o m Wo r l d H e a l t h Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. This recognition has attracted foreign regulatory agencies to undergo training in NPRA. Throughout 2017, NPRA received six visitors from Brunei Darussalam, Nepal and Sri Lanka.

NPRA as a WHO Collaborating Centre for Regulatory Control of Pharmaceuticals

NPRA provided training to these officers from other regulatory agencies such as The National Medicines Regulatory Authority Sri Lanka, National Medicines Quality Assurance Laboratory Sri Lanka, Department of Drug Administration Nepal and Ministry of Health Brunei Darussalam. The scope of training includes Good Manufacturing Practice inspection, equipment qualification & validation, Chemical & microbiological testing on Pharmaceutical, Health Supplements & Traditional Products as well as the post-registration activities such as surveillance & pharmacovigilance of medicines.

The 4th Session of the Islamic Conference of Ministers of Health (ICHM), which was held in Jakarta on 22 – 24 October 2013, adopted the OIC Strategic Health Programme of Action 2014 - 2023 (OIC-SHPA), which was prepared and submitted by SESRIC in collaboration with OIC member countries and relevant international organisations.

The OIC-SHPA was prepared with a view to strengthen and enhance cooperation and

NPRA’s involvement in activities at the OIC level

collaboration on various health issues at both OIC and international level. The OIC-SHPA identified six thematic areas for joint action and Malaysia was elected as the lead country coordinator for Thematic Area 4: Medicine, Vaccine and Medical Technologies. As the lead country, Malaysia ensures the activities planned under this Thematic Area are carried out in a timely manner. Malaysia also participates and gives input for other Thematic Areas when required.

2017ANNUAL REPORT


Malaysia actively participates in the OIC meetings such as the Lead Country Coordinators Meeting (LCC) and the Steering Committee of Health Meeting (SCH) which is carried out annually, as well as the International Conference of the Health Ministers Meeting (ICHM) which is held once in every two years.

In 2017, NPRA’s representative, Mdm. Siti Aida Abdullah attended the 5th LCC meeting as well as the 12th SCH Meeting held in Jeddah, Kingdom of Saudi Arabia from the 5 – 7 November 2017. The outcome of these meetings was brought into the 6th ICHM for approval.

Malaysia through NPRA continues to carry out activities such as in-depth training sessions to assist OIC member states to improve the regulatory control of medicines and vaccines in their country. NPRA believes that having a strong

regulatory control system in place will promote better access to good quality, effective and safe medicines and vaccines.

Publications

These publications can be downloaded from NPRA’s official website at http://npra.moh.gov.my/index.php/recent-updates/publication.

In addition, NPRA also published several guidelines in 2017, namely the Malaysian Variation Guideline for Biologics (MVGB) and the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products.

These guidelines can also be downloaded from NPRA’s official website at http://npra.moh.gov.my/index.php/guidelines-central.

2017ANNUAL REPORT

http://npra.moh.gov.my/index.php/recent-updates/publication

http://npra.moh.gov.my/index.php/recent-updates/publication

http://npra.moh.gov.my/index.php/guidelines-central

http://npra.moh.gov.my/index.php/guidelines-central


FINANCIAL REPORTOPERATING BUDGET 2017

Objek Code Category Allocation Expenditure Balance

(RM) RM % RM %10000 Emolument 37,693,827.00 38,816,860.27 102.98% -1,123,033.27 -2.98%

20000 Service & Supply 12,934,607.00 12,761,099.71 98.66% 173,507.29 1.34%

30000 Asset 0.00 0.00 0.00% 0 0.00%

40000 Gift and Fixed Payment 37,900.00 29,855.68 78.77% 8,044.32 21.23%

50000 Refund 69,650.00 69,650.00 100.00% 0 0.00%

TOTAL 50,735,984.00 51,677,465.66 101.86% -941,481.66 -1.86%

DEVELOPMENT BUDGET 2017

Objek Code Category

Allocation Expenditure Balance(RM) RM % RM %

060400 Pharmacy Regulatory 48,709,635.00 49,661,480.64 101.95% (951,845.64) -1.95%

010100 HQ management 3,000.00 - 0.00% 3,000.00 100.00%

040200 Engineering 113,799.00 112,260.20 98.65% 1,538.80 1.35%

110200 Contract Staff Emolument 400.00 391.43 97.86% 8.57 2.14%

022501 (B11)

NBOS innitiative 34,500.00 29,464.25 85.40% 5,035.75 14.60%

040101 (B11) Refund 69,650.00 69,650.00 100.00% - 0.00%

120100Management Program Stregthening

5,000.00 4,830.00 96.60% 170.00 3.40%

110400 Privatization PSH 1,800,000.00 1,799,389.14 99.97% 610.86 0.03%

TOTAL 50,735,984.00 51,677,465.66 101.86% (941,481.66) -1.86%

2017ANNUAL REPORT


Revenue for 2017

Code Item Total(RM)

72199

Registration of Cosmetic Product 5,379,050.00

New Product Registration 2,407,500.00

Product Re-registration 3,500,000.00

Veteriner Product Registration 105,000.00

Product Re-registration Veteriner 23,000.00

Free Sale Certificate 276,000.00Change of Holder 277,500.00Change of Holder (Veteriner) 0.00Change of Site 114,000.00Change of Site (Veteriner) 0.00Export Product Registration 77,500.00Classifications of Drugs 776,850.00

73301 Selling of Asset 418.00

71499

Clinical Import License 153,500.00Manufacturer License 261,000.00Import License 231,000.00Manufacturer’s License 467,000.00

72499

GMP Invoice Abroad 794,500.00GMP Invoice 591,200.00Good Manufacturing Practice 88,000.00GMP Certificate 33,350.00BE Invoice 431,000.00Vaccine Lot Release 145,800.00

73999 Other Sales 2,309.25

Total 16,135,477.25

2017ANNUAL REPORT


NATIONAL PHARMACEUTICAL REGULATORY AGENCYBAHAGIAN REGULATORI FARMASI NEGARA

36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.Tel : +603-7883 5400 Faks : +603-7956 2924

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annual report - npra.gov.my · between medicine regulators globally is visible now more than ever....

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