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Product Regulation & Liability

Singapore: HSA issues transition plan for compliance with the requirement for Evidence of Good Manufacturing Practice

By 3 Mins Read

In brief

On 29 September 2023, the Health Sciences Authority (HSA) rolled out a one-year transition plan for companies to fully comply with the requirement for chemical drug substance (DS) manufacturers to provide Evidence of Good Manufacturing Practice (GMP) Compliance. 

The HSA also provided clarity over the types of evidence that companies can submit as proof of GMP compliance.

Background

The full implementation of the requirement for GMP compliance evidence for chemical DS manufacturers aims to align the GMP requirements for both chemical and biological DS manufacturers.

By requiring all DS manufacturers to comply with the GMP requirements, companies can better assure customers of the quality of therapeutic products supplied in Singapore.

The requirement for Evidence of GMP Compliance for all DS manufacturers will apply prospectively to New or Generic Drug Applications (NDA or GDA) and Minor Variation Applications (MIV-1) for the addition of a new DS manufacturer.

Dates of Implementation

From 1 October 2024 onwards, NDAs, GDAs and MIV-1 applications must be supported by the required GMP compliance evidence for DS manufacturers. Applications submitted on or after 1 October 2024 without the required GMP compliance evidence will not be accepted.

From now until 30 September 2024, the HSA strongly encourages companies to provide Evidence of GMP Compliance where available, to ensure a smooth transition when the requirement is fully implemented.

Types of GMP compliance evidence

Companies may submit any of the following GMP compliance evidence to support the NDA, GDA and/or MIV-1 applications:

  1. A valid GMP certificate issued by any Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority.

    For PIC/S authorities that do not issue GMP certificates, either the GMP inspection report together with the close-out letter, where applicable, or other evidence from the authority to demonstrate that the site complies with PIC/S GMP requirements can be submitted. Such other GMP evidence must cover the DS of interest and may include a GMP certificate with the DS of interest stated, a GMP inspection report or manufacturing license with the DS of interest included in the scope, or a written confirmation (using the European Union template or any other official document from the PIC/S authority) for the DS of interest from the PIC/S authority that issued the GMP certificate;
     
  2. A valid Active Pharmaceutical Ingredient (API) Registration Certificate covering the DS of interest listed on EUDRAGMP; or
     
  3. A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest issued by EUDRAGMP.

Further information on the implementation and a list of frequently asked questions (FAQs) can be found here.

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For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.

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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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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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