Version update of eCTD package
HSA is in the process of updating the eCTD package taking into consideration the consulation feedback. An updated eCTD specification package (version 1.0) will be published by Q2 2024. This will be the version used for preparing eCTD submissions to HSA.
The initial version 0.9 which was released in May 2023 was for consultation purposes only and will not be implemented.
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.
For more information on eCTD submissions, please email us at HSA_TP_ectd@hsa.gov.sg