Product registration and post approval variation

Main guidance

• Guidance on Therapeutic Product Registration in Singapore1276 KB (updated June 23)

Appendices

• Appendix 1 Patent Declaration Forms731 KB (updated June 23)

• ICH CTD checklists
  • Appendix 2A Application checklist for NDA and GDA (ICH CTD)196 KB (updated June 23)
  • Appendix 2B Application checklist for MAV (ICH CTD)81 KB (updated June 23)

• ACTD checklists
  
  • Appendix 3A Application checklist for NDA and GDA (ACTD)187 KB (updated June 23)
  • Appendix 3B Application checklist for MAV (ACTD)82 KB (updated June 23)

• Appendix 4 Sample Verification Document for Translator7 KB 

• Appendix 5 Target Processing Timelines171 KB

• Appendix 6 Guideline on Submission for Non-Prescription Therapeutic Products165 KB

• Appendix 7 Points to Consider for Singapore Labelling131 KB 

• Appendix 7A Guidance on Electronic Labelling for Therapeutic Products92 KB 

•  Appendix 8 Guideline on the Registration of Human Plasma-derived Therapeutic Products79 KB

• Appendix 9 Guideline on the Registration of Human Therapeutic Products Containing Materials of Animal Origin219 KB

• Appendix 9A Checklist for Registration of Human Therapeutic Products Containing Materials of Animal Origin24 KB

• Appendix 10 Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications267 KB 

• Common questions related to generic drug applications 

• Appendix 11 Guidance on Drug Master File180 KB (updated June 23)

• Appendix 11A [obsolete]
• Online DMF Submission Form
• Appendix 11B Sample Letter of Access for DMF298 KB

• Appendix 12 MIV self-guided tool for post-approval Variation Selection (updated June 23)

• MIV online enquiry form

• Appendix 13 Guidance on MIV Applications for Chemical Therapeutic Products980 KB 

• Appendix 13A Part A: Checklist on Dossier Requirements for MIV 1 Variation for Chemical Therapeutic Products84 KB 
• Appendix 13B Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Chemical Therapeutic Products93 KB 
• Appendix 13C Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Chemical Therapeutic Products83 KB 

• Appendix 14 Guidance on MIV Applications for Biological Therapeutic Products689 KB 

• Appendix 14A Part A: Checklist on Dossier Requirements for MIV-1 Variation for Biological Therapeutic Products70 KB (updated Jun 23)
• Appendix 14B Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Biological Therapeutic Products58 KB 
• Appendix 14C Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Biological Therapeutic Products55 KB 

• Appendix 15 [obselete]
• Appendix 16 Guideline on Submission Requirements for Risk Management Plan Documents166 KB 

• Appendix 16A Singapore-Specific Annex (SSA) Template (PDF version)118 KB   (Word version)37 KB

• Appendix 17 Guideline on PRISM Submission2144 KB (updated Jun 23)

• Appendix 18 Confirmation of Quality Dossiers with Reference Agency's Approval357 KB 

• Appendix 18A Dossier Clarification Supplement169 KB (Word version) 38 KB 

Retention on Therapeutic Product Register

• Guidance for Retention of Therapeutic Product on the Product Register266 KB 

Change of registrant

• Guidance on Change of Registrant for Registered Therapeutic Product178 KB 

ASEAN Common Technical Dossier (ACTD)

ASEAN Registration of Pharmaceuticals for Human Use

• Organisation of the Dossier107 KB
• Glossary used for the ACTD and ACTR306 KB
• Part II: Quality198 KB
• Part III: Nonclinical Document869 KB
• Part IV: Clinical Document346 KB
• ACTD Clinical Check List for Product Classification165 KB

ASEAN Common Technical Requirements (ACTR)

• ASEAN Variation Guideline Rev 2 (2021)274 KB
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (includes all annexes)983 KB
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration149 KB
  • Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products230 KB
  • Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products142 KB
  • Annex A3 Guidance on Process Validation Scheme for Terminally Sterilised Products117 KB
  • Annex B Table of Content of Process Validation Documentation82 KB 
  • Annex C Guidance for Quality By Design as an Alternative Approach to Process Validation308 KB
  • ANNEX D48 KB
• ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies592 KB
• ASEAN Guideline on Stability Study of Drug Product (R1)1161 KB
• ASEAN Guideline for Validation of Analytical Procedures122 KB
• ASEAN Guideline on Process Validation Q&A123 KB
• ASEAN Guideline on Analytical Validation Q&A149 KB
• ACTR for Pharmaceuticals Registration Quality145 KB
• ACTR for Safety and Efficacy159 KB
• Q&A for Stability Guideline on Vaccine80 KB
• Q&A on ASEAN Stability Guideline62 KB

Dealer's licensing and certification

Good Distribution Practice (GDP) guides

• Guidance Notes on Good Distribution Practice (GUIDE-MQA-013)263 KB  
• Guidance Notes on Preparation of a Site Master File for Good Distribution Practice Certification (GUIDE-MQA-022)227 KB
• Guidance Notes on Duties of Responsible Persons Named in the Importer's Licence and Wholesaler's Licence (GUIDE-MQA-028) 140 KB

Good Manufacturing Practice (GMP) guides

For GMP related documents, please refer to HSA | Good Manufacturing Practice and Good Distribution Practice Standards.

HSA guides

• Preparation of a Quality System Dossier (GUIDE-MQA-019)271 KB
• GMP Conformity Assessment of an Overseas Manufacturer (GUIDE-MQA-020)493 KB
• Guidance on Secondary Packaging of Therapeutic and Medicinal Products (GUIDE-MQA-031)455 KB
• Guidance on the Licensing, GMP Certification and Inspection of Therapeutic Products Manufacturers (GUIDE-MQA-034)1399 KB

Retail pharmacy licensing

• Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and other Medicinal Products via Automated Vending Machines (GUIDE-MQA-029)141 KB
• Guidance Notes on Supply of Registered Therapeutic Products through e-pharmacy (GUIDE-MQA-032)521 KB
• Guidance Notes on Retail Supply of Registered Therapeutic Products (Pharmacy Only Medicines and Prescription Only Medicines) via Vending Machines (GUIDE-MQA-035)263 KB

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for Therapeutic Products

• Guidance for Industry: Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products519 KB

• FAQ on Risk Management Plan275 KB

Reporting of Therapeutic Product Defects and Recall of Therapeutic Products

• Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products449 KB
• 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.

• Online Product Defect Reporting Form
• Online Product Recall Completion Form

Advertisements and promotions

• Explanatory Guidance to the Health Products (Advertisement of Therapeutic Products) Regulations383 KB
• Guidance for PHMCA / HCSA Licensees and Telemedicine Service Providers: Advertisement Controls of Health Products and Provision of Non-Promotional Information to the Public288 KB

Special Access Routes (SAR)

• Guidance for Application to Import a Therapeutic Product on Consignment Basis241 KB (for non-authorised importers) (updated Jun 23)
•  Guidance for Import and Supply of an Unregistered Therapeutic Product for Patient Use220 KB (updated Jul 23)      
  • Signed Request form for Named-Patient Application Type164 KB (updated Jul 23)
  • Signed Request Form for Buffer Stock Application Type172 KB (updated Jul 23)
• Special Consignment by a Product Registrant 
  • Annex 1: Quality differences between Singapore-registered product and consignment product140 KB

Clinical trials of therapeutic products

Refer to our clinical trials section for the guidance documents.