Summary of Responses to Feedback from Public Consultation on the Proposed Regulation for Cell, Tissue and Gene Therapy Products under the Health Products Act

1. The Health Sciences Authority (HSA) initiated a Public Consultation from 6 November to 27 November 2020 on the 2 new pieces of legislation for Cell, Tissue and Gene Therapy Products (CTGTP):
   a. Proposed Health Products Act (Amendment of First Schedule) Order 2020; and
   b. Proposed Health Products Act (Cell, Tissue and Gene Therapy Products) Regulations 2020

2. A total of 83 responses from 18 respondents were received at the close of the Public Consultation. The summaries of the respondents and feedback by category are provided in Table 1 and Table 2.

3. Most of the feedback on the 2 pieces of legislation for CTGTP sought clarifications on the definitions of various terminologies, classification of CTGTP, licensing conditions and duties, post market requirements, import and supply of an unregistered CTGTP, and impact to CTGTP that were allowed under the current Medical Devices Special Access Route (MDSAR). HSA has compiled a set of Frequently Asked Questions (FAQ) based on the responses received. The FAQ can be accessed here [PDF, 288 KB]

4. The feedback and comments received on the technical guidelines on Good Manufacturing Practice and Good Distribution Practice related to CTGTP will be taken into consideration as we refine these guidelines.

Table 1: Respondents by Category

Table 2: Feedback by Category

5. HSA would like to thank all stakeholders who have participated in the public consultation and prior focus group discussions related to the CTGTP regulations. The feedback received has helped to refine the proposed Regulations to facilitate patients’ access to medically important therapies that meet the appropriate standards of safety, efficacy and quality.

HEALTH PRODUCTS REGULATION GROUP
HEALTH SCIENCES AUTHORITY
6 JANUARY 2021