Guidance documents for therapeutic products
Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.
Last updated 26 May 2026
Product registration and post approval variation
Main guidance
Guidance on Therapeutic Product Registration in Singapore (updated Jan 2026)
Appendices
Appendix 1 Patent Declaration Forms
ICH CTD checklists (Excel)
ACTD checklists (Excel)
Appendix 6 Guideline on Submission for Non-Prescription Therapeutic Products
Appendix 8 Guideline on the Registration of Human Plasma-derived Therapeutic Products
Appendix 10 Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications
Appendix 11A [obsolete]
Appendix 12 MIV self-guided tool for post-approval Variation Selection
Appendix 13 Guidance on MIV Applications for Chemical Therapeutic Products
Appendix 14 Guidance on MIV Applications for Biological Therapeutic Products
Appendix 15 [obsolete]
Appendix 16/16A [obsolete]
Appendix 17 Guideline on PRISM Submission (updated Jan 2026)
Appendix 18 Confirmation of Quality Dossiers with Reference Agency's Approval
Retention on Therapeutic Product Register
Change of registrant
ASEAN Common Technical Dossier (ACTD)
ASEAN Registration of Pharmaceuticals for Human Use
ASEAN Common Technical Requirements (ACTR)
Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products [PDF, 231 KB]
Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products [PDF, 143 KB]
Annex A3 Guidance on Process Validation Scheme for Terminally Sterilised Products [PDF, 118 KB]
Annex B Table of Content of Process Validation Documentation [PDF, 83 KB]
ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies [PDF, 593 KB]
ASEAN Guideline on Stability Study of Drug Product (R2) [PDF, 816 KB]
ASEAN Guideline for Validation of Analytical Procedures [PDF, 123 KB]
Dealer's licensing and certification
Good Distribution Practice (GDP) guides
Good Manufacturing Practice (GMP) guides
For GMP related documents, please refer to HSA | Good Manufacturing Practice and Good Distribution Practice Standards.
HSA guides
Retail pharmacy licensing
Safety monitoring and product recall
Post-Marketing Vigilance Requirements for Therapeutic Products
Reporting of Therapeutic Product Defects and Recall of Therapeutic Products
Video guide on product defect reporting and recall in Singapore. This video brings you through the considerations on whether a product defect needs to be reported to us, and the steps to report the defect or recall the product.
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Special Access Routes (SAR)
Clinical trials of therapeutic products
Refer to our clinical trials section for the guidance documents.