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In brief

The Therapeutic Products Branch of the Health Sciences Authority (HSA) has provided an interim update on the progress of the eCTD implementation in Singapore following an industry consultation held between 2 May 2023 to 12 June 2023.


Background

As updated in our previous alert of May 2023, the HSA intends to implement 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 implementation was envisaged to take place in phases and adoption by the industry will be on a voluntary basis during the initial roll-out. 

Further details on the background may be accessed in our previous alert here.

Post-industry consultation updates

Following the feedback provided by industry stakeholders, the HSA has provided an interim update on the key changes that are underway:

1. Issuance of unique e-identifier via the eCTD portal to be used as the applicable folder name.

Companies will no longer need to generate a universal unique identifier (UUID) and separately construct an application folder name with their PRISM application number. The issuance of the unique e-identifier which serves as the applicable folder name will help reduce the high likelihood of error that was present in the previous approach. 

2. Updating of specification document to clarify the order of submission and including business workflow illustrations for baseline and transfer submissions.

These changes seek to remedy the lack of clarity on the submission procedures relating to a company’s use of online portals and requirements for baseline submissions. 

3. Introduction of option to submit multiple dosage forms, presentations or strengths as separate or single applications.

Further directions relating to the submission procedures and module organization for submitting multiple dosage forms or presentations in a single eCTD application will be provided. 

4. Inclusion of regional stylesheet in the specification components package to facilitate viewing of envelop information.

This would serve to facilitate the viewing of the envelope information.

5. Refinement of validation criteria to permit electronic signatures on PDF documents.

Prior to this change, electronic signatures were prohibited due to the security settings specified in the validation criteria.  

* * * * *

The HSA intends to incorporate the above changes and publish an updated eCTD specification package (version 1.0) by the second quarter of 2024. 

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Author

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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