The Health Sciences Authority (HSA), a statutory board of the Ministry of Health (MOH), invites public feedback on a new piece of legislation, the proposed Health Products (Active Ingredients) Regulations 2023. The consultation period will be from 17 July 2023 to 17 August 2023.
2 Active ingredients1 are pharmacologically active substances that may be used to manufacture health products including therapeutic products, cell tissue or gene therapy products, and medical devices. Active ingredients are currently regulated under the Poisons Act 1938 and Medicines Act 1975. Under the current regulations, importers and wholesalers are required to be licensed under the Poisons Act and manufacturers are encouraged to apply for voluntary Good Manufacturing Practice (GMP) certification, under the Medicines Act.
3 With the increasing complexity in the manufacturing and supply chain of active ingredients, streamlined and risk-based regulatory controls will ensure that active ingredients consistently meet the appropriate quality standards. To achieve this, HSA will be consolidating and enhancing the regulatory controls for active ingredients under one single Act – the Health Products Act (HPA). When the proposed Health Products (Active Ingredients) Regulations 2023 is implemented, the regulatory controls of active ingredients under the Poisons Act 1938 and Medicines Act 1975 will no longer apply.
Proposed Health Products (Active Ingredients) Regulations 2023
4 The objectives of the proposed Health Products (Active Ingredients) Regulations 2023 are:
(i) To safeguard public health by ensuring that active ingredients are consistently manufactured, stored and distributed with the quality standards appropriate for their intended use.
(ii) To provide a fit-for-purpose and risk-based licensing framework for active ingredients that aligns with international standards and enhances mutual confidence with overseas counterparts.
(iii) To streamline the regulation of active ingredients under a single legislation through the HPA, providing greater clarity on the legal requirements and regulatory controls for all active ingredient manufacturers, importers and wholesalers.
Key proposed legislative changes and regulatory controls
(A) Scope of Active Ingredients Regulatory Controls
5 The Health Products (Active Ingredients) Regulations is proposed to regulate active ingredients that are specified in The Schedule of the Regulations and are usable as pharmacologically active constituents in the manufacture of any of the following health products:
• Therapeutic Products
• Cell Tissue or Gene Therapy Products that are not a result of only minimal manipulation of cell or tissue
• Medical Devices
(B) Risk-Based Regulatory Controls
6 Risk-based regulatory controls refer to activity-based licensing of manufacturers, importers and wholesalers of active ingredients based on their risk profiles:
• Inspection and licensing controls will apply to all manufacturers, importers and wholesalers of active ingredients used in health products for local clinical use. Such companies handling active ingredients will be inspected for compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) Guide or HSA Good Distribution Practice (GDP) standard.
• Importers and/or wholesalers performing lower risk activities where the active ingredients are intended for non-clinical purposes such as scientific research, use in animals and other applications not involving humans, will be subjected to less stringent requirements. HSA shall reserve the rights to inspect, as required.
• Licensed importers and wholesalers of active ingredients will no longer need to hold a separate Form A Poisons Licences under the Poisons Act.
7 HSA welcomes feedback on the proposed regulations for active ingredients. The feedback will help in refining the proposed regulatory framework.
9 Please provide your name, name of the organisation you represent, contact number and email address. We may contact you to clarify your enquiries if necessary. Where possible, you should highlight the provisions in the proposed draft Regulations for which you are providing feedback.
10 Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence if the information is proprietary, confidential, or commercially sensitive. HSA will not publish such feedback publicly and will respond to you, if needed, in confidence.
HEALTH SCIENCES AUTHORITY
1 " Active Ingredients" under the Health Products Act is also commonly referred to as "Active Pharmaceutical Ingredients" in the industry.