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Product Regulation & Liability

Singapore: Health Sciences Authority updates guidance on implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) manufacturers

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In brief

In October 2024, the Health Sciences Authority (HSA) updated its Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers (“Guidance“).

This is a timely amendment to the Guidance as the requirement for chemical DS manufacturers to provide evidence of GMP compliance became mandatory with effect from 1 October 2024, after a one-year grace period.

In more detail

With effect from 1 October 2024, all new or generic drug applications (NDA or GDA) and minor variation applications (“MIV-1“) for adding a new DS manufacturer must be supported by GMP compliance evidence for DS manufacturers. Applications that fail to meet these requirements will not be accepted.

The Guidance clarifies that this mandatory requirement does not apply to existing registered products, except when an MIV-1 application is submitted for addition or replacement of manufacturer/site of drug substance.

Only GMP certificates issued by a Pharmaceutical Inspection Co-operation Scheme authority will be accepted; the HSA will not accept certificates issued by third-party certification schemes.

The requirement for evidence of GMP compliance is intended to align the requirements for both chemical and biological DS manufacturers, and the HSA has clarified that the GMP evidence requirements for chemical and biologic DS manufacturers are similar.

Key takeaways

The HSA regularly updates and provides guidance on its regulatory requirements and processes to maintain clarity for its stakeholders.

You may refer to our previous update here for other initiatives made by the HSA to enhance its processes and systems and better assure the quality of therapeutic products supplied in Singapore for patients.

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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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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.

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