As part of Singapore HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, has updated the regulatory requirement for Therapeutic Product Registration, which includes the following:
1. New submission pathway for standard essential medicines – This new submission pathway enables the registration of standard essential medicines through Generic Drug Applications (GDA). To qualify, a standard essential medicine must have a well-established efficacy and safety profile documented in recognised references. This pathway is designed for unregistered medicines that have a long history of local clinical use and are critical for Singapore’s healthcare system, allowing them to leverage the established local clinical use as evidence for safety and efficacy. Products with a corresponding Singapore reference product are not eligible for this pathway.
2. Removal of limit of concurrent submissions for major variation applications (MAV-1) – The previous limit of three concurrent MAV-1 submissions in PRISM has been removed, providing greater flexibility when submitting MAV-1 applications.
3. Good Manufacturing Practice (GMP) Conformity Assessment of overseas drug substance (DS) manufacturing sites – This new procedure allows companies to request HSA to conduct a GMP inspection for overseas DS manufacturing site where the site lacks the required evidence of GMP compliance at the point of submitting a registration application for a New Chemical / Biologic Entity (NCE / NBE).
4. Declaration of conflict of interest by company-engaged experts – For clarity and transparency, any statements of opinion by expert clinicians submitted by applicants to support an application must be accompanied by the expert clinicians’ written declaration confirming they have no conflict of interest in relation to the application.
Please visit the following HSA’s announcement page for further details: https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-updates-for-therapeutic-product-registration-(effective-16-jan-26)
To view the updated HSA guidelines, please refer to this link: https://www.hsa.gov.sg/therapeutic-products/guidance-documents