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 30 June 2026
Product registration and post approval variation
Main guidance
Appendices
Appendix 1 Patent Declaration Forms
ICH CTD checklists (Excel)
ACTD checklists (Excel)
Appendix 4 Sample Verification Document for Translator (opens in new tab)
Appendix 6 Guideline on Submission for Non-Prescription Therapeutic Products (opens in new tab)
Appendix 7 Points to Consider for Singapore Labelling (opens in new tab)
Appendix 11A [obsolete]
Appendix 12 MIV self-guided tool for post-approval Variation Selection (opens in new tab)
Appendix 13 Guidance on MIV Applications for Chemical Therapeutic Products (opens in new tab)
Appendix 14 Guidance on MIV Applications for Biological Therapeutic Products (opens in new tab)
Appendix 15 [obsolete]
Appendix 16/16A [obsolete]
Appendix 17 Guideline on PRISM Submission (opens in new tab)
Appendix 18 Confirmation of Quality Dossiers with Reference Agency's Approval (opens in new tab)
Retention on Therapeutic Product Register
Change of registrant
ASEAN Common Technical Dossier (ACTD)
ASEAN Registration of Pharmaceuticals for Human Use
Glossary used for the ACTD and ACTR [PDF, 307 KB] (opens in new tab)
Part III: Nonclinical Document [PDF, 439 KB] (opens in new tab)
ACTD Clinical Check List for Product Classification [PDF, 166 KB] (opens in new tab)
ASEAN Common Technical Requirements (ACTR)
ASEAN Variation Guideline Rev 2 (2021) [PDF, 275 KB] (opens in new tab)
ASEAN Guideline on Stability Study of Drug Product (R2) [PDF, 816 KB] (opens in new tab)
ASEAN Guideline for Validation of Analytical Procedures [PDF, 123 KB] (opens in new tab)
ASEAN Guideline on Process Validation Q&A [PDF, 124 KB] (opens in new tab)
ASEAN Guideline on Analytical Validation Q&A [PDF, 150 KB] (opens in new tab)
ACTR for Pharmaceuticals Registration Quality [PDF, 146 KB] (opens in new tab)
ACTR for Safety and Efficacy [PDF, 160 KB] (opens in new tab)
Q&A for Stability Guideline on Vaccine [PDF, 81 KB] (opens in new tab)
Q&A on ASEAN Stability Guideline [PDF, 63 KB] (opens in new tab)
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 (opens in new tab) 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.
Advertisements and promotions
Special Access Routes (SAR)
Guidance for Application to Import a Therapeutic Product on Consignment Basis (opens in new tab) (for non-authorised importers)
Clinical trials of therapeutic products
Refer to our clinical trials section for the guidance documents.