In more detail
On 30 July 2025, the HSA released the following key regulatory updates for the registration of therapeutic products:
1. Enhancement of application checklists for NDA, GDA and MAV submission
The HSA’s application checklists for new drug application (NDA), generic drug application (GDA) and major variation application (MAV) submissions (Appendix 2A, 2B, 3A and 3B) have been revised. The new checklists, in MS Excel format, will replace the old checklists that are in MS Word format. The old checklists will continue to be accepted until 31 October 2025, giving applicants time to familiarize themselves with the new format. The documents can be found here.
The HSA intends for these changes to help improve usability for applicants, serving as a submission aid to ensure the completeness of application dossiers and reduce screening queries.
2. Clarification on prerequisite documents for acceptance of application for screening
The HSA has clarified that applications will not be accepted for screening if any of the following prerequisite documents are omitted:
- Module 3/Part 2 Drug Substance dossier
- Module 3/Part 2 Drug Product dossier
- Module 4/Part 3 Non-Clinical dossier (if applicable)
- Module 5/Part 4 Clinical dossier
- Drug Master File (DMF) and its accompanying Letter of Access (if applicable)
- Assessment report from Reference Agencies (for verification route)
- Duly completed Application Checklist in MS Excel format
- Duly completed Patent Declaration Form
3. Updated acceptable proof of GMP compliance for drug product manufacturing sites
The HSA has updated its Good Manufacturing Practice (GMP) documentary evidence to align with the latest version of the guidance on “GMP Conformity Assessment of An Overseas Manufacturer, version December 2024.”
The update concerns the acceptable proof of GMP compliance issued by a competent authority for NDA, GDA and MIV-1/2 applications. This proof may be in the form of either of the following:
- Valid PIC/S GMP Certificate (Certificate of GMP Compliance)
- Establishment Inspection Report and close out letter issued by US/FDA
The proof of compliance must be valid at the time of submission and must have at least six months remaining before expiry.
4. Introduction of a new online form for DMF submission
The HSA has streamlined the Drug Master File (DMF) submission process. Applicants are no longer required to submit a separate DMF receipt acknowledgement issued by the HSA in their product registration application. Instead, DMF holders can now notify the HSA and obtain a DMF reference number for submission of the dossier using a new online form.
5. Streamlining of dossier requirements for MAV-1 verification evaluation route
The HSA now accepts complete assessment reports obtained from the public domain for the primary reference agency to support MAV-1 applications via the verification evaluation route.
6. Enhancement of criteria for forensic classification of therapeutic products (POM/P/GSL)
The HSA has enhanced the regulatory considerations for POM, P and GSL to facilitate and provide clarity on the criteria for reclassification.
Key takeaways
The HSA regularly updates its regulatory requirements and processes to ensure that they are efficient and clear for its stakeholders. These updates also reflect the HSA’s continued collaboration efforts with key industry stakeholders, taking in the relevant feedback to further enhance its processes and systems.
These updates will be relevant to those making or intending to make applications for therapeutic products in Singapore. If you require advice on the detailed requirements, please contact us.
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