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Health Sciences Authority

Cell, Tissue and Gene Therapy Products

HSA regulates the registration, import, manufacture and supply of Cell, Tissue and Gene Therapy Products (CTGTP) in Singapore. Find out what the requirements are.

Last updated 29 April 2026

Overview of regulatory requirements

Understand the scope of regulations on cell, tissue and gene therapy products (CTGTP) in Singapore

Class 1 CTGTP Notification

Find out how to complete your notification of Class 1 CTGTP with HSA before supplying the product in Singapore.

Class 2 CTGTP Registration

Find out the requirements for Class 2 CTGTP registration.

Manufacturing, import and wholesale

Understand the licensing requirements before you import, wholesale and manufacture cell, tissue and gene therapy products (CTGTP) in Singapore.

Post-market surveillance, safety monitoring and advertisement

Find out the requirements related to post-market surveillance, safety monitoring and advertisement.

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).

Fees and turnaround time for CTGTP

Here is the list of fees and turnaround time to help you with your CTGTP transactions.

Useful links