HSA-NPRA Generic Medicines Work Sharing Initiative

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The HSA-NPRA Generic Medicines Work Sharing Initiative is a work sharing model for the joint collaborative assessment of a generic medicine registration application filed with both the Health Sciences Authority (HSA) of Singapore and the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. This initiative aims to enhance leveraging regulatory expertise, reduce regulatory burden and facilitate market entry of generic medicines.

We are glad to announce that we are currently in the midst of evaluating an immediate release oral solid dosage form (supported by bioequivalence data) as the pilot to this initiative. Hence, we will not be accepting any more applications at the moment. We will continue to update this page with more information from time to time.

Please refer to the following documents for more details on the work sharing initiative.

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 27 November 2020, 10:09:22.
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