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Product Regulation & Liability

Singapore: Health Sciences Authority proposes regulation for active ingredients under the Health Products Act

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In brief

On 17 July 2023, the Health Sciences Authority (HSA) proposed the new regulation for active ingredients under the Health Products Act.

Against 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 appropriate quality standards. The HSA has therefore seen the need to consolidate and enhance regulatory controls for active ingredients under the Health Products Act. 

In more detail

Background

Active ingredients are pharmacologically active substances that may be used to manufacture health products, including therapeutic products, cell tissue or gene therapy products, and medical devices. They are presently regulated under the Poisons Act and Medicines Act.

To consolidate and enhance regulatory controls so that the manufacture and supply of active ingredients consistently meet appropriate quality standards, the HSA has proposed consolidating the regulatory controls for active ingredients under the Health Products Act. Once the regulation under the Health Products Act is implemented, regulatory controls for active ingredients under the Poisons Act and the Medicines Act will no longer apply.

Objectives

The HSA’s key objectives driving the proposed new regulation for active ingredients under the Health Products Act are the following:

  • To safeguard public health by ensuring the consistent manufacture, storage and distribution of active ingredients with quality standards appropriate for the intended use
  • To provide a fit-for-purpose and risk-based licensing framework aligned with international standards and to increase mutual confidence with overseas counterparts
  • To streamline the regulation of active ingredients under a single legislation and to increase clarity of legal requirements and regulatory controls

Key proposed legislative changes

First, the proposed regulation will specify in a schedule the active ingredients that will be regulated. These scheduled active ingredients would be those that are usable as pharmacologically active constituents in the manufacture of therapeutic products, cell tissue or gene therapy products that are not a result of only minimal manipulation of cell or tissue, and/or medical devices.

Second, the HSA will adopt a risk-based regulatory approach for activity-based licensing of manufacturers, importers and wholesalers of active ingredients based on their risk profiles.

For instance, inspection and licensing controls will apply to all manufacturers, importers and wholesalers of active ingredients used in health products for local clinical use. In contrast, importers and/or wholesalers performing lower-risk activities where active ingredients are intended for non-clinical purposes such as scientific research, use in animals and other applications not involving humans, will be subject to less stringent requirements.

Licensed importers and wholesalers of active ingredients will no longer need to hold a separate Form A Poisons License under the Poisons Act.

The proposed new regulation may be accessed here.

Public consultation

The HSA welcomes feedback on the proposed regulation for active ingredients. Feedback may be provided here until 17 August 2023.

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Author

Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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