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ECTD submissions

Submit documents in a standardised electronic format for therapeutic product registration.

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.   


Resources for Industry

Download the package as a ZIP file: SG-HSA Specification Components (806KB)


Download the package as a ZIP file: SG-HSA Validation Components (96 KB) (updated 9 May 23)

Contact Us

For more information on eCTD submissions, please email us at