Singapore HSA Updates Therapeutic Product Registration Guidelines

As part of Singapore’s Health Sciences Authority (HSA) ongoing initiative to improve regulatory efficiency and enhance clarity in Therapeutic Products’ regulatory requirements and processes, HSA announced some regulatory changes made to Therapeutic Product guidance documents, with the updates taking effect from 30 July 2025.

The update to the guidelines include the following:

1. Enhancement of application checklists for NDA, GDA and MAV submission
2. Clarification on prerequisite documents for acceptance of application for screening
3. Updated acceptable proof of GMP compliance for drug product manufacturing sites
4. Introduction of a new online form for DMF submission
5. Streamlining of dossier requirements for MAV-1 verification evaluation route
6. Enhancement of criteria for forensic classification of TPs (POM/P/GSL)
7. Other revisions

Please refer to the following for the official announcement published by HSA:

https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-updates-for-therapeutic-product-registration-(effective-30-july-25)

To view the updated guidelines, please visit the following HSA website: https://www.hsa.gov.sg/therapeutic-products/guidance-documents