About the HSA-NPRA Generic Medicines Work Sharing Initiative
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.
Please refer to the following documents for more details on the work sharing initiative and how to apply:
- Notice to applicants571 KB
- Operational procedures678 KB
Applicants who are interested to participate in this pilot can submit your completed Expression of Interest (EOI) form17 KB to us via email to HSA_TP_Enquiry@hsa.gov.sg (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”:
- HSA (Singapore): HSA_TP_Enquiry@hsa.gov.sg
- NPRA (Malaysia): email@example.com