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Health Sciences Authority

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 10 July 2026

Is my product a Cell, Tissue and Gene Therapy Product?

Answer a few questions in our self-help tool to find out if your product is considered a CTGTP in Singapore.

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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

Major Variation (MAV-1) Guide

Minor variation (MIV) Guide

Other useful links:

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

Clinical trials

Refer to our clinical trials section for the guidance documents.