Public Consultations
Summary of Responses to Feedback from Public Consultation on the Proposed Regulation for Active Ingredients under the Health Products Act
Audiences
Healthcare professional
Industry member
Product type
Controlled drugs
Psychotropic substances and poisons
17 October 2023
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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 [PDF, 181 KB].
Table 1: Respondents by Category
Table caption
Category | Number of Respondents | Number of Responses/Comments |
|---|---|---|
Industry | 15 | 58 |
Educational Institution | 1 | 1 |
Total | 16 | 59 |
Table 2: Feedback by Category
Table caption
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