Summary of Responses to Feedback from Public Consultation on the Proposed Regulation for Active Ingredients under the Health Products Act

The Health Sciences Authority (HSA) initiated a Public Consultation from 17 July 2023 to 17 August 2023 on the Proposed Regulation for Active Ingredients under the Health Products Act.

1. A total of 59 responses from 16 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.

2. Most of the feedback on the proposed regulation for Active Ingredients sought clarifications on the definition of active ingredients, transition approach for existing manufacturers and dealers, duties and requirements for licensees and management of recalls. HSA has compiled a set of Frequently Asked Questions (FAQ) based on the responses received. The FAQ can be accessed here.

Table 1: Respondents by Category

Category	Number of Respondents	Number of Responses/Comments
Industry	15	58
Educational Institution	1	1
Total	16	59

 

Table 2: Feedback by Category

Brief Description of Feedback	Number of Responses/Comments	%
Clarification on licensing and regulatory requirements	17	29
Clarification on duties of licensees	16	27
Clarification on transition approach, application process and fees	12	20
Clarification on definition of active ingredient	8	14
Clarification on recalls	4	7
Other enquiries not related to the regulations	2	3
	59	100

 

3. HSA would like to thank all stakeholders who have participated in the public consultation and prior focus group discussions on the regulation for Active Ingredients. The feedback received has helped to refine the proposed regulatory framework to ensure that active ingredients are consistently manufactured, stored and distributed with the quality standards appropriate for their intended use.

HEALTH PRODUCTS REGULATION GROUP
HEALTH SCIENCES AUTHORITY
17 OCTOBER 2023

Published: 17 Oct 2023

Public Consultations