Product registration and post approval variation

Main guidance

• Guidance on Cell Tissue and Gene Therapy Products Registration in Singapore623 KB  

Appendices

1. Guideline on Notification Process for Class 1 Cell, Tissue or Gene Therapy Product252 KB
• Form to list Class 1 Cell Tissue or Gene Therapy Products11 KB
2. Pre-Market Consultation for Class 2 Cell, Tissue or Gene Therapy Product Registration214 KB
3. NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)54 KB
4. NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ACTD Format)52 KB
5. Sample Verification Document for Translator107 KB
6. Target Processing Timelines for Class 2 CTGTP Applications104 KB
7. Points to Consider for Class 2 CTGTP Labelling97 KB
8. Chemistry, Manufacturing and Controls requirements for Cell, Tissue or Gene Therapy Product for Clinical Trials and Product Registration518 KB
• Checklist for the registration of Class 2 Cell, Tissue or Gene Therapy Product containing materials of animal origin32 KB
9. Guideline on the Submission of Risk Management Plan Documents112 KB      
   • Singapore Specific Annex (SSA) Template (PDF version)97 KB (Word version) 38 KB
10. Guideline on Minor Variation Application for Class 2 Cell, Tissue or Gene Therapy Products333 KB
• Part A Checklist on Dossier Requirements for MIV-1 Application53 KB
• Part B Checklist on Dossier Requirements for MIV-2 Application55 KB
11. Variation Application Filing and Submission Enquiry Form71 KB
12. MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)48 KB
13. MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ACTD Format)48 KB

Dealer's licensing and certification

Good Distribution practice (GDP) guides

• Guidance Notes on Good Distribution Practice 263 KB  

Good Manufacturing Practice (GMP) guides

HSA guides

• HSA Guidelines on Good Manufacturing Practice for CTGTP854 KB

PIC/S guides

• Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (PIC/S PE 008-4)

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for CTGTP

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

Reporting product defects and recall CTGTP

• 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

Clinical trials

Refer to our clinical trials section for the guidance documents.