Product registration and post approval variation

Main guidance

• Guidance on Therapeutic Product Registration in Singapore (Aug 21)1489 KB (updated 20 Aug 21)

Appendices

1. Patent Declaration Forms 431 KB
2. ICH CTD checklists
   • Application checklist for NDA and GDA (ICH CTD)187 KB (updated 20 Aug 21)
   • Application checklist for MAV (ICH CTD)81 KB (updated 20 Aug 21)
3. ACTD checklists
   
   • Application checklist for NDA and GDA (ACTD)187 KB (updated 20 Aug 21)
   • Application checklist for MAV (ACTD)82 KB (updated 20 Aug 21)
4. Sample Verification Document for Translator7 KB
5. Target Processing Timelines171 KB
6. Guideline on Submission for Non-Prescription Therapeutic Products165 KB
7. Points to Consider for Singapore Labelling152 KB 

• Guidance on Electronic Labelling for Therapeutic Products92 KB 

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

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

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

10. Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications95 KB

• Common questions related to generic drug applications 

11. Guidance on Drug Master File180 KB (updated 20 Aug 21)

• DMF Submission Form Template271 KB

• Sample Letter of Access for DMF298 KB

12. MIV self-guided tool for post-approval Variation Selection (updated 20 Aug 21)

• MIV online enquiry form

13. Guidance on MIV Applications for Chemical Therapeutic Products980 KB (updated 20 Aug 21)

• Part A: Checklist on Dossier Requirements for MIV 1 Variation for Chemical Therapeutic Products187 KB (Word version79 KB) (updated 20 Aug 21)
• Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Chemical Therapeutic Products318 KB (Word version85 KB) (updated 20 Aug 21)
• Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Chemical Therapeutic Products213 KB (Word version56 KB) (updated 20 Aug 21)

14. Guidance on MIV Applications for Biological Therapeutic Products689 KB (updated 20 Aug 21)

• Part A: Checklist on Dossier Requirements for MIV-1 Variation for Biological Therapeutic Products142 KB (Word version62 KB)(updated 20 Aug 21)
• Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Biological Therapeutic Products216 KB (Word version57 KB) (updated 20 Aug 21)
• Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Biological Therapeutic Products200 KB (Word version48 KB) (updated 20 Aug 21)

15. Guidance on Registration of Biosimilar Products254 KB

16. Guideline on Submission Requirements for Risk Management Plan Documents166 KB

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

17. Guideline on PRISM Submission2144 KB 

18. Confirmation of Quality Dossiers with Reference Agency's Approval357 KB (updated 20 Aug 21)

• Dossier Clarification Supplement169 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 (version 7.2)741 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

Dealer's licensing and certification

Good Distribution practice (GDP) guides

• GUIDE-13 Good Distribution Practice263 KB  
• GUIDE-22 Guidance Notes on Preparation of a Site Master File for Good Distribution Practice Certification269 KB
• GUIDE-28 Guidance Notes on Duties of Responsible Persons Named in the Importer's Licence and Wholesaler's Licence140 KB

Good Manufacturing Practice (GMP) guides

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

PIC/S guides

• Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products
• Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (PIC/S PE 008-4)
• Recommendation on Sterility Testing (PIC/S PI 012-3)
• Validation Master Plan, Installation and Operational Qualification, Non-sterile Process validation, Cleaning validation (PIC/S PI 006-3)
• Validation of Aseptic Processes (PIC/S PI 007-6)

WHO guides

• WHO Guide on Water Pharmaceutical Use
• WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms

Retail pharmacy licensing

• GUIDE-29 Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and other Medicinal Products via Automated Vending Machines141 KB
• GUIDE-32 Guidance Notes on Supply of Registered Therapeutic Products through e-pharmacy521 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 Products531 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 Products408 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) Regulations 2016279 KB
  • FAQ on Advertisement Controls for Therapeutic Products80 KB

Special Access Routes (SAR)

• Guidance for Application to Import a Therapeutic Product on Consignment Basis241 KB (for non-authorised importers)
•  Guidance for Import and Supply of an Unregistered Therapeutic Product for Patient Use220 KB 
  • Signed Request form for Named-Patient Application Type158 KB
  • Signed Request Form for Buffer Stock Application Type120 KB
• Special Consignment by a Product Registrant 
  • Application form for Special Consignment by a Product Registrant216 KB

Clinical trials of therapeutic products

Refer to our clinical trials section for the guidance documents.