National Pharmaceutical Control Bureau (NPCB)

The National Pharmaceutical Control Bureau (NPCB) Malaysia, formerly known as the National Pharmaceutical Control Laboratory, 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, NPCB 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 to medical profession and consumer was made available through a drug information service.

The NPCB also handles courses and provides training to personnel from the ASEAN countries, for example from Sri Lanka, Bangladesh, Myanmar, Mongolia and Vietnam.

In 1996, NPCB 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 NPCB's contribution in the field of regulatory affairs.

The main activities of NPCB are:

1. To implement the drug and cosmetic registration scheme through evaluation of technical data, laboratory test, research and information from international bodies.
   To carry out analytical, pharmaceutical, microbiological, pharmacological and toxicological tests on drugs and cosmetic to ensure quality, efficacy and safety of the products.
   To enforce a quality control scheme on drugs in the market through random sampling and test.
2. To enforce a licensing scheme for manufacturer, importer, wholesaler including licensing scheme for clinical trial.
   To encourage and assist local manufacturer to upgrade the manufacturing standards to levels equivalent to the requirements of Good Manufacturing Practice as recommended by WHO.
3. To manage adverse drug reaction monitoring programme and participate in the WHO Adverse Drug Reaction Monitoring Programme.
   To manage the product recall scheme for the pharmaceutical products which are found to be substandard or dangerous to the consumer.
   To manage the collection and dissemination of drug information in line with the role as a national drug information centre.
4. To carry out research on methodology for the purpose of evaluating quality, efficacy and safety of drug and cosmetic.
5. To establish a reference standard system for local use and neighbouring countries through a scheme of co-operation among ASEAN countries.
6. To carry out training for pharmacist, professional and semi professional who are placed in this institution from time to time under local training scheme or international co-operation scheme.