What is the role of NPRA in vaccine registration?

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MP SPEAKS | The National Pharmaceutical Regulatory Agency (NPRA) functions as the secretariat for the Drug Control Authority (DCA) to handle the application of registration of drugs, including vaccines.The DCA is the executive body established under the Control of Drugs and Cosmetics Regulations (CDCR) 1984, Regulation 3(1). The main task of this authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia.This objective is being achieved through the following:Licensing of premises for importer, manufacturer and wholesalerMonitoring the quality of registered products in the marketAdverse drug reaction monitoringThe CDCR 1984 was the legislation gazetted under the provisions of the Act 368, ie the Sale of Drug Act 1952.Under the CDCR 1984, Regulation 3 (2), the authority shall consist of the followin…