Product registration and post approval variation

Guidance on Cell Tissue and Gene Therapy Products Registration in Singapore690 KB  

Appendices

1. Documentary Requirements for Class 1 Cell Tissue and Gene Therapy Products Notification191 KB
2. Pre-Market Consultation for Class 2 Cell, Tissue or Gene Therapy Product Registration214 KB
3. NDA Checklist for Class 2 CTGTP (ICH CTD Format) (updated 2 September 2024)
4. NDA Checklist for Class 2 CTGTP (ACTD Format) (updated 2 September 2024)
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 Labelling198 KB (updated 14 March 2024)
8. Chemistry, Manufacturing and Controls requirements for Cell, Tissue or Gene Therapy Product for Clinical Trials and Product Registration518 KB
   • Checklist for Registration of Class 2 CTGTP containing materials of animal origin (updated 2 September 2024)
9. Guideline on the Submission of Risk Management Plan Documents  (updated 1 July 2024)   
10. Guideline on Minor Variation Application for Class 2 Cell, Tissue or Gene Therapy Products333 KB
11. Variation Application Filing and Submission Enquiry Form71 KB
12. MAV-1 Checklist for Class 2 CTGTP (ICH CTD Format) (updated 2 September 2024)
13. MAV-1 Checklist for Class 2 CTGTP (ACTD Format) (updated 2 September 2024)

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 CTGTP469 KB

• Singapore-Specific Annex (SSA)
• Safety Notification Form

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.