Class 1 CTGTP notification
Find out how to complete your notification of Class 1 cell, tissue or gene therapy product (CTGTP) with HSA before supplying the product in Singapore.
Suppliers of Class 1 CTGTP must notify HSA on the product and receive HSA's written acceptance of notification before the product can be supplied in Singapore.
The supplier would also be required to ensure that the product was sourced from an accredited/licensed facility and that it is free from infectious agents.
Refer to Appendix 1 Guideline on Notification Process for Class 1 Cell, Tissue or Gene Therapy Product252 KB to ensure the submission of a complete dataset for product notification.
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application: