Singapore: SHARE Portal for Cell, Tissue, & Gene Therapy Products Notification & Notices (CTGTP)

ARQon
Dec 12, 2023
1 min read

As part of providing a smooth regulatory process for cell, tissue, and gene therapy products (CTGTP) dealer’s notice and class 1 CTGTP notification, HSA presents a one-stop digital portal SHARE (Singapore Health Product Access and Regulatory E-System) and will be officially launched on 2 January 2024.

Hence, starting from the launching date, all new dealer notices or product notification submissions, updates, or active status checking can be made directly in the SHARE portal by using the company’s Corppass Administrator.

HSA will continue to process new submissions of the CTGTP Dealer’s Notice or Class 1 CTGTP Notification via FormSG until 31 December 2023 and any update submissions for CTGTP Dealer’s Notice or Class 1 CTGTP Notification via FromSG will be accepted until 18 December 2023.

Beyond the mentioned dates, all matters are required to be submitted directly to the SHARE portal starting from 2 January 2024. All existing data will be transferred to the SHARE portal and no actions required to be done by the companies. Further, no regulatory or submission requirements changes are to be implemented to the existing active companies.

Source: Health Sciences Authority (HSA)