Industry consultation for eCTD package from 2 May to 12 June 2023
Industry consultation is now closed, and HSA is reviewing the feedback received. The eCTD industry consultation package and briefing slides may be downloaded here. We aim to publish the summary of changes and updated eCTD specification package, including the Q&A document, on our website by Q1 2024.
eCTD (electronic common technical document) is the standard structured format for the electronic transfer of regulatory information related to therapeutic products from industry to health authorities. eCTD submissions minimise the need for using storage media such as CD/DVD ROMs for dossier submissions. It also allows better product life cycle management for both industry and HSA.
HSA will adopt a phased approach for eCTD implementation for therapeutic product submissions based on ICH eCTD specification 3.2.2.
Further guidance on eCTD submissions will be published closer to the target implementation date (estimated Q4 2024). Bookmark this page for the latest updates or subscribe to HSA announcements.
Contact Us
For more information on eCTD submissions, please email us at HSA_TP_ectd@hsa.gov.sg