As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, HSA updates Main Guidance on Therapeutic Product Registration and Appendices (with effect from 1 Aug 2024) due to the following regulatory updates:
1. Introduction of new tool for estimating key evaluation milestones for New Drug Application, Generic Drug Application and Major Variation Application; evaluated under full and abridged evaluation route
2. Introduction of new cloud-based platform for submission of application dossier and DMF via “EasiShare”, in addition to the existing submission modes via electronic media (CDs/DVDs) or HSA online system (PRISM)
3. A list of post-approval changes which do not require notification to HSA has been specified in the variation guidelines
4. Implementation of the Health Products (Therapeutic Products) (Amendment) Regulations 2024
5. Introduction of Swissmedic as HSA’s reference agency
6. Editorial changes and minor amendments to the guidelines
7. Implementation of GMP requirements for chemical DS manufacturers with effect from 1 Oct 2024
8. Streamlining of RMP requirements for biosimilar applications i.e. The submission of RMP documents, including the Singapore-Specific Annex (SSA), is no longer mandatory for biosimilar (NDA-2) applications, unless requested by HSA.
For more details, please visit the following HSA website for the related announcement: https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-updates-for-therapeutic-product-registration-(effective-1-aug-2024)
Updated HSA Guidance can be found here: https://www.hsa.gov.sg/therapeutic-products/guidance-documents