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Singapore: Health Sciences Authority holds industry consultation on electronic common technical document implementation

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In brief

The Therapeutic Products Branch of the Health Sciences Authority (HSA) is intending to implement electronic common technical document (eCTD) submissions in Singapore. eCTD is a standard structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions.

The eCTD will be implemented in phases, and adoption by industry will be on a voluntary basis during the initial roll-out. The HSA will provide advance notice to the industry on subsequent phases.

The HSA has invited industry stakeholders to participate in the industry consultation on eCTD submissions up until 12 June 2023.

In more detail

Background

The eCTD is the internationally recognised standard format for the electronic transfer of regulatory information to health authorities.

On 17 April 2023, the HSA issued a notice regarding the eCTD implementation to the industry. The HSA then published the eCTD specification package on 2 May. This package contains several documents, including draft eCTD specifications, validation component documents, and a Q&A document. Industry stakeholders were invited to provide comments on the eCTD specification package to facilitate the smooth implementation of eCTD in Singapore.

On 9 May 2023, the HSA held an industry briefing session on the implementation of the eCTD in Singapore where it provided an overview of the eCTD, including preparation, validation and submission through the eCTD portal.

Advantages of eCTD submissions

Introducing eCTD to enable full e-submissions minimises the need to use storage media (e.g., CD/DVD ROMs) and allows for better product life-cycle management for companies and the HSA.

The HSA has also consolidated a list of advantages of submitting regulatory information through the eCTD system instead of via the HSA’s present pharmaceutical regulatory information system (PRISM). These advantages include the following:

  • eCTD submissions through the portal are entirely paperless and have the advantage of system validation that ensures successful receipt of the package by the HSA.
  • Unlike how documents are attached in PRISM, eCTD would allow companies to submit common dossiers for multiple strengths in a single application and upload a single ZIP file.
  • eCTD enables content reuse without the need to re-submit documents.

Implementation of the eCTD

The eCTD will be implemented in phases, and adoption by industry will be on a voluntary basis during the initial roll-out. 
Presently, the HSA has published a Q&A document that addresses industry stakeholders’ issues regarding the eCTD, portal registration, content of eCTD submissions, document navigation, technical presentation, validation and post-marketing information.

The target implementation date for eCTD submissions in Singapore is Q4 2024. Further guidance on eCTD submissions will be published closer to the target implementation date.

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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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