Product registration and post approval variation

Main guidance

• Guidance on Therapeutic Product Registration in Singapore (updated January 2019)1793 KB

Appendices

1. Patent Declaration Forms (updated January 2019)431 KB
2. ICH CTD checklists
   • Application Checklist for NDA and GDA (ICH CTD)1149 KB (Word version187 KB)
   • Application Checklist for MAV (ICH CTD)638 KB (Word version80 KB)
3. ACTD checklists
   • Application Checklist for NDA and GDA (ACTD)1131 KB (Word version186 KB)
   • Application Checklist for MAV (ACTD)636 KB (Word version78 KB)
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 Labelling177 KB

• Guidance for Electronic Labelling Aug 2019 (draft version for pilot run) 230 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

• Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications95 KB

11. Guidance on Drug Master File180 KB

• DMF Submission Form Template271 KB

• Sample Letter of Access for DMF298 KB

12. MIV online enquiry form

• Self-guided tool for Post-Approval Variation Selection378 KB

13. Guidance on MIV Applications for Chemical Therapeutic Products980 KB

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

14. Guidance on MIV Applications for Biological Therapeutic Products689 KB

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

15. Guidance on Registration of Biosimilar Products254 KB

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

• Singapore-Specific Annex (SSA) Template424 KB

17. Guideline on PRISM Submission2056 KB

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

• 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 Practice240 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

• Audit and Licensing Of Pharmaceutical Manufacturers (GUIDE-MQA-002)188 KB
• Good Manufacturing Practice For Assemblers Of Medicinal Products (GUIDE-MQA-017)233 KB
• Guidance Notes on Product Quality Review (GUIDE-MQA-024)203 KB
• GUIDE-019 Preparation of a Quality System Dossier (GUIDE-MQA-019)271 KB
• GMP Conformity Assessment of an Overseas Manufacturer (GUIDE-MQA-020)200 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 sale of General Sale List (GSL) by Vending Machine

• GUIDE-29 Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and other Medicinal Products via Automated Vending Machines141 KB

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for Therapeutic Products

• Guidance for Industry- Post-Marketing Vigilance Requirements for Therapeutic Products500 KB
• FAQ on Risk Management Plan Industry Consultation275 KB

Reporting of Therapeutic Product Defects and Recall of Therapeutic Products

• Guidance for Industry- Reporting of Therapeutic Product Defects and Recall of Therapeutic Products300 KB
• FAQ on reporting of therapeutic product defects and recall of therapeutic products98 KB
• 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 on Import and Supply of Unregistered TP for patients use Sep 19489 KB
  • Signed Request form274 KB
• Special Consignment by a Product Registrant 
  • Application form for Special Consignment by a Product Registrant116 KB

Clinical trials of therapeutic products

Refer to our clinical trials section for the guidance documents.