“Singapore HSA’s Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective 25 September 2024. The eCTD Specification package version 1.0 is now available for industry stakeholders to prepare for test and actual eCTD submission in advance of the system rollout tentatively scheduled in March 2025.
HSA’s target launch date of eCTD portal is March 2025. The system will be open for test submissions during the first 6 months from March to September 2025. The contents of test submissions will not be reviewed and will be deleted from the system once testing is complete. Thereafter, only actual submissions for product applications will be accepted.
HSA will adopt a phased approach for eCTD implementation for therapeutic product submissions based on ICH eCTD specification 3.2.2. The use of eCTD for dossier submission will be on a voluntary basis. The initial launch will be open to new drug applications, generic drug applications and their corresponding Drug Master File (DMF) submissions.
For further detail on HSA’s announcement and e-CTD implementation, please visit the following weblink:
– https://www.hsa.gov.sg/announcements/regulatory-updates/release-of-sg-hsa-specification-package-v1.0-for-electronic-common-technical-document-(ectd)-implementation-in-singapore
– https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions”