Guidance documents for CTGTP
Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue and gene therapy products (CTGTP).
Last updated 26 May 2026
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Product notification, registration or variation
Class 1 CTGTP Notification
Class 1 CTGTP Notification Guide
Class 2 CTGTP Registration
Class 2 CTGTP Registration Guide
Class 2 CTGTP Variation Applications
MIV Checklist for Class 2 CTGTP [PDF, 419 KB] (updated 15 January 2026)
Other useful links:
GMP conformity assessment for overseas manufacturers of CTGTP
CMC Requirements for CTGTP for Clinical Trials and Product Registration [PDF, 526 KB]
Points to consider for Class 2 CTGTP Labelling [PDF, 217 KB]
Guidance on CTGTP Registration and Variation Applications in Singapore [PDF, 492 KB] (Updated 15 January 2026)
Dealer's licensing and certification
Good Distribution practice (GDP) guides
Good Manufacturing Practice (GMP) guides
HSA guides
PIC/S guides
Special Access Routes (SAR)
Safety monitoring and product recall
Post-Marketing Vigilance Requirements for CTGTP
Reporting product defects and recall CTGTP
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.
Clinical trials
Refer to our clinical trials section for the guidance documents.