Product registration and post approval variation

Main guidance

• Guidance on Therapeutic Product Registration in Singapore1276 KB (updated Aug 22)

Appendices

• Patent Declaration Forms731 KB (updated Apr 22)

• ICH CTD checklists
  • Application checklist for NDA and GDA (ICH CTD)196 KB (updated Apr 22)
  • Application checklist for MAV (ICH CTD)81 KB 

• ACTD checklists
  
  • Application checklist for NDA and GDA (ACTD)187 KB (updated Apr 22)
  • Application checklist for MAV (ACTD)82 KB 

• Sample Verification Document for Translator7 KB (updated Apr 22)

• Target Processing Timelines171 KB

• Guideline on Submission for Non-Prescription Therapeutic Products165 KB

• Points to Consider for Singapore Labelling131 KB (updated Apr 22)

• Guidance on Electronic Labelling for Therapeutic Products92 KB 

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

• 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

• Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications267 KB (updated Apr 22)

• Common questions related to generic drug applications 

• Guidance on Drug Master File180 KB (updated Apr 22)

• DMF Submission Form Template271 KB

• Sample Letter of Access for DMF298 KB

• MIV self-guided tool for post-approval Variation Selection (updated  Apr 22)

• MIV online enquiry form

• Guidance on MIV Applications for Chemical Therapeutic Products980 KB (updated July 22)

• Part A: Checklist on Dossier Requirements for MIV 1 Variation for Chemical Therapeutic Products84 KB (updated July 22)
• Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Chemical Therapeutic Products93 KB (updated July 22)
• Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Chemical Therapeutic Products83 KB (updated July 22)

• Guidance on MIV Applications for Biological Therapeutic Products689 KB (updated Apr 22)

• Part A: Checklist on Dossier Requirements for MIV-1 Variation for Biological Therapeutic Products70 KB (updated Apr 22)
• Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Biological Therapeutic Products58 KB (updated Apr 22)
• Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Biological Therapeutic Products55 KB (updated Apr 22)

• Guideline on Submission Requirements for Risk Management Plan Documents166 KB (updated Apr 22)

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

• Guideline on PRISM Submission2144 KB (updated Apr 22)

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

• Dossier Clarification Supplement169 KB (Word version) 38 KB (updated Apr 22)

Retention on Therapeutic Product Register

• Guidance for Retention of Therapeutic Product on the Product Register266 KB (updated Apr 22)

Change of registrant

• Guidance on Change of Registrant for Registered Therapeutic Product178 KB (updated Apr 22)

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

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 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) 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) (updated Apr 22)
•  Guidance for Import and Supply of an Unregistered Therapeutic Product for Patient Use220 KB (updated Mar 2023)      
  • Signed Request form for Named-Patient Application Type164 KB (updated Mar 2023)
  • Signed Request Form for Buffer Stock Application Type172 KB (updated Mar 2023)
• 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.