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Product Regulation & Liability

Singapore: Regulatory updates for therapeutic product registration | August 2024

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In brief

On 31 July 2024, the Health Sciences Authority (“HSA“) released updates to the registration of therapeutic products as part of its continued efforts to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes.

Key takeaways

The HSA regularly updates its regulatory requirements and processes to ensure that they are efficient and clear for its stakeholders. Such updates also reflect the HSA’s continued collaboration efforts with key industry stakeholders, taking in the relevant feedback to further enhance its processes and systems.

In more detail

On 31 July 2024, the HSA released key regulatory updates for the registration of therapeutic products:

  1. Implementation of GMP requirements for chemical DS manufacturers

The requirement for Evidence of Good Manufacturing Practice (GMP) Compliance for manufacturers of chemical drug substances (DS) will be fully implemented on 1 October 2024.

The GMPE Requirements state that New or Generic Drug Applications (NDA or GDA) and Minor Variation Applications (MIV-1) for addition of a new DS manufacturer are to be supported by the required GMP Compliance Evidence for DS manufacturers.

The implementation of the GMPE Requirements is meant to align the requirements for both chemical and biological DS manufacturers. This forms part of the HSA’s continual regulatory enhancements to assure the quality of therapeutic products supplied in Singapore. Its full implementation will enable companies to better assure the quality of therapeutic products supplied in Singapore for patients.

  1. New tool for estimating key evaluation milestones for NDA, GDA and MAV-1 full and abridged application

The HSA has introduced a webtool for applicants to estimate the key application milestone timelines for NDAs, GDAs and Major Variation Applications (MAV-1s). This is based off specific timepoints that the HSA has issued, e.g., applicants can expect to receive the first evaluation Input Request (IR) in:

  • 160 working days for NDA/MAV-1 applications under the full evaluation route
  • 120 working days for NDA/MAV-1 applications under the abridged evaluation route
  • 150 working days for GDA applications under the abridged evaluation route
  1. New cloud-based platform for submission of application dossier and DMF “EasiShare”

Companies now have a new option of submitting their dossiers via a cloud-based file exchange software (EasiShare) in addition to the existing submission modes via electronic media (CDs/DVDs) or PRISM.

  1. Guidelines on post-approval changes that do not require notification to the HSA

A list of post-approval changes that do not require notification to the HSA has been published in Section 4 of Appendix 13: Guideline on MIV Applications for Chemical Therapeutic Products and Appendix 14: Guideline on MIV Applications for Biological Therapeutic Products.

For example, the notification of product labelling changes related to machine-readable codes (e.g., QR codes) for e-labelling is no longer required.

  1. Streamlining of risk management plan requirements for biosimilar applications

As of April 2024, the submission of risk management plan (RMP) documents, including the Singapore-Specific Annex (SSA), is no longer mandatory for biosimilar (NDA-2) applications, unless requested by HSA. The submission of RMP documents is still required for NDA-1 applications.

  1. Introduction of Swissmedic as HSA’s reference agency

Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, has been added as one of HSA’s reference agencies, along with the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Health Canada, UK Medicines and Healthcare Products Regulatory Agency (MHRA), and Australia Therapeutic Goods Administration (TGA).

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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.

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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