The National Pharmaceutical Control Bureau (NPCB) is an institution established by the Ministry of Health Malaysia in 1978. It is a regulatory agency charged with the responsibility of quality assurance and regulatory affairs of pharmaceuticals.
The gazetting of the Control of Drugs and Cosmetics Regulations 1984 marked the beginning of a systematic regulatory control of pharmaceuticals marketed in Malaysia. The basic objective of this legislation is to ensure safety, efficacy and quality of pharmaceutical products used by the public for health care.
Under the Asean Technical Co-operation among Developing Countries (Asean TCDC) Program, NPCB has been chosen and recognised by the Asean countries as the regional training centre for quality control of pharmaceuticals. NPCB has been the host for the training program in quality control and has successfully conducted such training since 1986. Apart from that, NPCB has been receiving trainees from Asean and other countries countries including Myanmar, Bangladesh, Vietnam, Pakistan, Philippines, Indonesia, India, Sri Lanka, Thailand, Macao, Singapore, Hong Kong, Laos, Cambodia and Mongolia. NPCB officers have been sent to Sri Lanka, Mongolia and Vietnam as consultants.
In view of the technical expertise and training capabilities of NPCB, it received the recognition as a "WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals" on 10 May 1996.
The designation of NPCB as a WHO Collaborating Centre for regulatory Control of Pharmaceutical is effective for a new period of 4 years from 1-Aug-2011.
TERMS OF REFERENCE
- To provide training in all aspects of pharmaceutical quality assurance programme and regulatory matters, both in the region as well as globally;
- To carry out product analysis for reference purposes or on behalf of countries lacking quality control laboratories;
- To collaborate closely with WHO in drug regulatory matters especially in the field of Prequalification both in assessment and inspection;
- To contribute to WHO work on the International Pharmcopeia and on activities related to the establishment of new International Chemical Reference Substances (ICRS); and
- To collaborate with WHO in the monitoring of Phamacovigilance / Adverse Drug Reactions reports as well as dissemination of information pertaining to products with quality defects and/or safety concerns.