National Pharmaceutical Regulatory Agency (NPRA) Malaysia
Date: 14 November 2017

NPRA is the Drug Regulatory Authority under the Ministry of Health of Malaysia. Formerly known as the National Pharmaceutical Control Bureau (NPCB), NPRA 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 that 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 also set-up.

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 vaccines through Vaccine Lot Release activities.

Malaysia welcomes all OIC member states to visit NPRA’s website. For more information & updates on regulatory control of medicinal products & cosmetics, please visit: