Class 1 CTGTP notification

Overview

Suppliers of Class 1 CTGTP must  submit a product notification and receive HSA's written acceptance of the 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, and ensure that all information provided in the Class 1 CTGTP notification is accurate and up to date.

Submit an update notification within 14 days of any change to the information provided earlier in the product notification. These changes may include, but are not limited to, administrative changes to the 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.

For changes to the tissue procurement sites and manufacturers of the Class 1 CTGTP, you will be required to submit a new Class 1 CTGTP notification.

Documents required

Refer to Appendix 1 Documentary Requirements for Class 1 Cell Tissue and Gene Therapy Products Notification191 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 applications through the Singapore Health product Access and Regulatory E-system (SHARE).

Ensure you have the following before doing so:

• CRIS company account and note your client code for billing
• Corppass

Cancellation of Notified Products

If you no longer intend to supply a notified Class 1 CTGTP, you can cancel the product notification in SHARE. Once the product is cancelled, it will be removed from the list of Notified Class 1 Cell, Tissue and Gene Therapy Products and the supply of the product is no longer allowed.