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Product Regulation & Liability

Singapore: Regulatory updates for therapeutic product registration

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In brief

On 28 March 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 as efficient and clear as possible. Such updates also reflect the HSA’s continued collaboration efforts with key industry stakeholders, taking in the relevant feedback to further enhance its processes.

In more detail

On 28 March 2024, the HSA released four main regulatory updates for the registration of therapeutic products:

  1. Launch of pilot program to extend electronic labelling (“e-labelling”) to pharmacy-only and General Sale List therapeutic products

E-labelling is currently implemented for prescription-only medicines in Singapore. As part of a calibrated approach in consultation with industry stakeholders, from 1 April 2024 onwards, the HSA will launch a pilot program to assess the feasibility of extending e-labelling to pharmacy-only and General Sale List therapeutic products.

  1. Revision of “Appendix 7: Points to Consider for Singapore Labelling” of the HSA’s Guidance on Therapeutic Product Registration in Singapore

The following changes to the abovementioned guidance has come into effect from 28 March 2024. These changes include the following:

  1. Removal of mandatory requirement for manufacturing date to be reflected on the outer carton/inner label.
  2. Flexibility for either the manufacturer, product owner or registrant’s name and address to be included on the outer carton/ inner label.
  3. Removal of mandatory requirement for precautionary statement on interchangeability of biosimilar products in the package insert.
  4. Minor editorial updates.
  5. Collaborations under Project Orbis

Project Orbis is an initiative of the US Food and Drug Administration (FDA) Oncology Center of Excellence. It provides a framework for the collaborative review of oncology products among international regulatory partners. Project Orbis is coordinated by the FDA, and it involves the regulatory authorities of the following countries: Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom. Online resources on Project Orbis are now available on the HSA website.

  1. Clarification on criteria for expedited review of pending minor variations (MIV) applications

The HSA has actively taken into consideration requests made by companies for expedited reviews of their MIV applications. To streamline the review process and minimise indiscriminate requests, the HSA will introduce an online request form to guide applicants on the eligibility criteria.

An expedited review request must meet one of the following criteria:

  1. There is no equivalent or alternative therapeutic option to the product in the Singapore market.
  2. The product is urgently required for supply under the National Procurement by ALPS.
  3. The requested change is mandatory and forms a crucial part of the National Procurement by ALPS.

While the HSA remains committed to ensuring supply continuity of therapeutic products in Singapore, companies should carefully plan their MIV submissions, taking into account the regulatory review timelines as appropriate.

Any expedited review requests should be accompanied by appropriate justifications, including the reasons for any delays in making the MIV submission. An expedited review request can be made using the online form here. The HSA will assess each request and the accompanying justifications and provide the outcome of the request via email within five working days.

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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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