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HISTORY

The National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB), was set up in October 1978 under the quality control activity of Pharmacy and Supply Programme. 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.

Beginning 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed. A system to monitor products in the market was set-up. Information on drugs for medical professionals and consumers was made available through a drug information service.

The NPRA also handles courses and provides training to drug regulatory personnel from the other countries, for example from Sri Lanka, Bangladesh, Myanmar, Mongolia and Vietnam.

In 1996, NPRA was given an international recognition by the World Health Organisation (WHO) as a "WHO Collaborating Centre for Regulatory Control of Pharmaceuticals". This recognition is an acknowledgement from WHO for NPRA's contribution in the field of regulatory affairs.

VISION

Enhancing our nation’s health through excellence in the practice of pharmacy.

MISSION

i. Uphold legislation and improve policies to ensure the quality of pharmaceutical products and services. 

ii. Ensure effective and responsive organisational system towards sustainable quality services.

iii. Build capabilities and professionalism through talent development and workforce empowerment.

iv. Intensify collaboration towards best practices and standards.

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

OBJECTIVE

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

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The members of MADRAC (Malaysian Adverse Drug Reactions Advisory Committee) are selected based on their qualifications and expertise with regard to their respective fields of practice. They serve on the Committee for a renewable period of three years.

MADRAC Members Session 2025 - 2027

NOMINATION CRITERIA FOR THE MADRAC MEMBERS

1.      MADRAC shall consist of the following members:

1.1      Three (3) members in their ex-officio capacity:

a)      Director of National Pharmaceutical Regulatory Agency (NPRA) - Chairperson

b)      Secretary of DCA, NPRA

c)      Deputy Director Centre for Compliance and Quality Control, NPRA - Secretary

1.2      Sixteen (16) members appointed by the Director General of Health.

2.      Criteria for nominating the MADRAC members are as follows:

2.1      Consultant Specialists/ Senior Consultant Specialists from MOH nominated by the respective heads of services/departments:

                          i.    2 consultant physicians

                         ii.    1 consultant dermatologist

                        iii.    1 consultant rheumatologist

                        iv.    1 consultant psychiatrist

                         v.    1 consultant nephrologist

                        vi.    1 consultant pediatrician

                       vii.    1 consultant oncologist

                      viii.    1 consultant with expertise in vaccines

                        ix.    1 pharmacist from the Pharmaceutical Services Programme

                         x.    1 pharmacist from a public health facility (hospital/health clinic)

a)  Must have at least 2 years of service with MOH remaining;

b)  Not among the members/alternate members of DCA

2.2      A pharmacist from a Public Institution of Higher Learning, and nominations will be requested from universities with teaching hospitals

a)  Must have at least 2 years of service with the Ministry of Higher Education remaining;

b)  Not among the members/alternate members of DCA

2.3      Representative from the private healthcare sector

i.    1 member of the Malaysian Pharmaceutical Society (MPS)

ii.   1 member of the Association of Private Hospitals Malaysia (APHM)

iii.  1 member from the Malaysian Medical Association (MMA)

iv.  1 member from the Federation of Private Medical Practitioner’s Association, Malaysia (FPMPAM)

a)  Must possess relevant professional qualifications (doctor or pharmacist) and experience;

b)  Must have retired from the Public Service

3.      Alternate members:

       In respect of appointed members, an alternate member shall be similarly qualified as the substantive member and appointed by the Director General of Health, Malaysia.

4.      All members of MADRAC are appointed by the Director General of Health for a term of 3 years.

If you have any queries regarding the appointment of MADRAC members, please contact the NPRA Pharmacovigilance Section at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Last updated: 30 Apr 2025