Regulatory Updates
INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE
Audiences
Industry member
Product type
Therapeutic Products
17 April 2023
The Therapeutic Products Branch (TPB) is pleased to inform industry of the upcoming consultation on eCTD submission for therapeutic products. The consultation will be held from 2 May 2023 to 12 June 2023.
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1. Overview
The eCTD is the internationally recognised standard format for the electronic transfer of regulatory information to health authorities. HSA is planning to introduce eCTD to enable full e-submissions thereby minimising the need for submitting documents using storage media such as CD/DVD ROMs. In addition, eCTD has the advantage of allowing better product life cycle management for both the companies and HSA.
HSA is working with our appointed vendor (Lorenz Life Sciences group and partners) to develop the eCTD system (ICH eCTD version 3.2.2) in Singapore. The initial launch will be open to new drug applications, generic drug applications and their corresponding Drug Master File (DMF) submissions. HSA will adopt a phased approach and the use of eCTD for dossier submissions will be on a voluntary basis.
2. Industry Consultation
Industry stakeholders and interested parties will be invited to participate in the consultation on eCTD. The purpose of the consultation is to provide an opportunity for industry to comment and submit feedback on the eCTD regulatory package for Singapore which will be published on 2 May 2023. This package includes the Singapore Regional Specification document, Module 1 Envelope Attributes and Defined Lists, Heading Elements and eCTD Validation Criteria. Your feedback is important for us to understand the potential impact on industry stakeholders and to ensure a smooth implementation of eCTD in Singapore.
3. Industry Briefing session
As part of the consultation, we will also be holding an Industry Briefing Session on 9 May 2023 at 2pm via Zoom webinar. Industry stakeholders and eCTD software vendors are invited to attend. Registration is now open and interested parties may sign up for the session using this form (closing date: 4 May 2023). Further details will be provided at a later date.
Subscribe to the HSA announcements page here, or visit the eCTD webpage, to keep up to date with the latest eCTD developments.