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 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 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
9. Guideline on the Submission of Risk Management Plan Documents     
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 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 Products454 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.