Roles and Functions

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To implement the drug registration / cosmetic notification scheme through evaluation of technical data, laboratory analysis, research and information received from international agencies.

To carry out analytical, pharmaceutical, microbiological and pharmacological tests on drugs and cosmetics to determine quality, efficacy and safety of such products.

To implement the regulatory scheme on quality of pharmaceutical products in the market through random sampling and carrying out analytical tests.

To implement the licensing scheme for pharmaceutical manufacturers, importers and wholesalers including a licensing scheme for clinical trial.

To encourage and assist local pharmaceutical manufacturers to upgrade manufacturing standards to levels equivalent to the requirements of Good Manufacturing Practice as recommended by the World Health Organisation (WHO).

To manage the Adverse Drug Reaction Monitoring Program and participate in the WHO International Adverse Drug Reaction Monitoring Program.

To manage the product recall scheme for pharmaceutical products which are found to be substandard or dangerous to consumers.

To disseminate information on policies/news of the Drug Control Authority (DCA) via the newsletter "Berita Ubat-ubatan" as well as provide service in the aspect of explaining to the public on the process of on-line registration, information on registered products and other queries pertaining to NPRA.

To carry out research on methodology and basic research for the purpose of evaluating quality, efficacy and safety of drugs/ cosmetics.

To carry out training for pharmaceutical regulatory officers as well as other professional and semi-professional officers through local training scheme or international cooperation scheme.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 14 December 2018, 08:46:08.
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