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Asia: Singapore and Malaysia launch the HSA-NPRA generic medicines work sharing initiative

2021/08/31  HSA

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.

As a pilot, we are looking for a potential candidate of an immediate release oral solid dosage form supported by bioequivalence data.

Applicants who are interested to participate in this pilot can submit your completed Expression of Interest (EOI) form17 KB to us via email to [email protected] (Singapore). The hardcopy completed EOI form must also be submitted to the Director of NPRA (Malaysia).
For further information, please contact us as follows with the email subject “HSA-NPRA Generic Medicine Work Sharing Initiative”:

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