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The Drug Control Authority of Malaysia: Pharmaceutical Regulatory Regime Examined

June 10, 2002

The Drug Control Authority (DCA) is the regulatory agency charged with regulating pharmaceutical products in Malaysia. Established under the Control of Drugs and Cosmetic Regulation 1984 (CDCR), the DCA's main task is to ensure the quality, safety, and efficacy of pharmaceutical and related products that are marketed and sold in Malaysia. To this end, the primary tasks of the DCA are: (1) registration of pharmaceutical products; (2) licensing of importers, manufacturers, and wholesalers; (3) monitoring the quality of registered products; and (4) adverse drug reaction monitoring.

Registration is required for all pharmaceutical products and traditional medicines in Malaysia. Each registered drug is given a registration number, which must be printed on its label or package. As of July 1, 2002, all registered health products must also be printed with the words “Di luluskan oleh Kementerian Kesihatan Malaysia” and “Jauhi daripada kanak-kanak,” which mean “Approved by the Ministry of Health” and “Keep away from children” respectively.

To register a pharmaceutical product, a foreign company exporting to Malaysia must first appoint a local agent. The local agent will be responsible for all matters pertaining to registration and will hold the registration certificate. The processing fee for a registration application is RM 250 (US$66), however, this amount is only a fraction of the fees DCA may charge an applicant for laboratory investigations and testing. Foreign medical companies with their own offices in Malaysia can and do register their products in their own name directly.

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