Find out about the collaboration with the National Pharmaceutical Regulatory Agency of Malaysia (NPRA) in the 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:
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”:
Regulatory overview
Register your product
Apply for post-approval variation
Reclassify your product
Dealer's licensing and certification
Retain, cancel or transfer product registration
Risk management plan requirements
Report adverse events
Report or recall defective products
Retail pharmacy licensing
Clinical trials
Product consultation
Advertisements and promotions
CPP and SLS
International collaboration
Medicines quality and compliance monitoring
Listing of approvals and post-registration actions
Guidance documents
Fees and turnaround time
PRISM (Therapeutic products)
Infosearch