Class 1 CTGTP notification

Find out how to complete your notification of Class 1 cell, tissue and gene therapy products (CTGTP) with HSA before supplying the product in Singapore.

New/update notification

New/update notification

Currently, Class 1 CTGTP are excepted from product registration.

However, suppliers of Class 1 CTGTP must submit a product notification and receive HSA's written acceptance of the notification before supplying the product in Singapore.

Similarly, any changes to a Notified Class 1 CTGTP need to be notified with HSA:

  • For changes to the tissue procurement sites and manufacturers of the Class 1 CTGTP, submit a new Class 1 CTGTP notification.
  • For other administrative changes like changes in accreditation status of the tissue procurement sites and manufacturers (such as changes to AABB, AATB, EBAA, FACT, CAP certificates or tissue bank licence with new expiry date following re-audit), product label and shelf-life, submit an update notification within 14 days of the change.

The supplier is also responsible to ensure:

  • the product was sourced from an accredited/licensed facility and that it is free from infectious agents
  • all information provided in the Class 1 CTGTP notification is accurate and up to date
  • compliance with the duties and obligations of dealing in a Class 1 CTGTP

Documents required

Refer to Documentary Requirements for Class 1 CTGTP Notification and Updates to ensure the submission of a complete dataset for product notification.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

Cancel notification

Cancel a Notified CTGTP

If you no longer intend to supply a notified Class 1 CTGTP, you can cancel the product notification.

Once the product is cancelled, it will be removed from the list of Notified Class 1 CTGTP and the supply of the product is no longer allowed.

How to apply

Submit your applications through SHARE.