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Foreign GMP Inspection

A company applying to the National Pharmaceutical Control Bureau (NPCB) for the registration of a medicinal product in Malaysia must provide acceptable evidence to show that the manufacturer of the product follows an internationally accepted standard of Good Manufacturing Practice (GMP) and recognized by the authority in Malaysia.

The Control of Drugs and Cosmetics Regulations 1984 (CDCR) requires that the standard of manufacture and quality control of medicinal products manufactured outside Malaysia be taken into consideration before the products are registered with the authority namely Drug Control Authority (DCA). NPCB as the secretariat to the DCA is responsible to ensure all manufacturers of registered products in Malaysia are able to provide acceptable evidence that the manufacturing premises conform to current GMP requirements. Hence, foreign manufacturers are also subjected to GMP conformity assessments through acceptable GMP evidence or GMP inspection.

 

(Updated : July 2016)

 

 

 

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