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Health Sciences Authority
Regulatory Updates

Regulatory Updates for Therapeutic Product Registration

30 September 2026

Audiences

Industry member

Product type

Therapeutic Products

As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in our regulatory requirements and processes, Therapeutic Products Branch (TPB) is pleased to update industry on the following:

1. Revision of Guidance on PRISM Submission (Appendix 17) (September 2026)

TPB has revised Appendix 17 following the review of feedback received during consultation with industry stakeholders.  The revised appendix defines a packaging configuration which describes how a product is supplied, and guidance on how to determine if a product should be submitted as an individual registration or submitted as multiple packaging configurations under a single product registration.

Appendices 2A, 3A, 13A, 14A are also updated to reflect the changes in Appendix 17.

These changes will take effect from 30 September 2026. Please refer to the updated guidance documents (opens in new tab) for detailed information.

2. Update on MIV checklist revision

HSA is reviewing and updating the Minor Variation (MIV) Checklist. The revised checklist will be published for industry consultation from mid-November to mid-December 2026. Details on the consultation process and feedback submission arrangements will be shared alongside the revised checklist.