Update of SG-eCTD version 1.1 package
The Therapeutic Products Branch (TPB) would like
to update industry that the SG-eCTD version 1.1 package and the
accompanying summary of changes from v 1.0 have been published on HSA website. The package is
available for download as a ZIP file.
SG-eCTD version 1.1 will be the official standard
for actual eCTD submissions with effect from 1 April 2026.
The current SG eCTD v1.0 package will be removed from
the HSA website after the test submission period ends on 27 March
2026. Companies planning to submit their application dossiers via
eCTD from April onwards should coordinate with their solution providers to
ensure that the necessary technical updates are implemented.
TPB is developing a platform for online access to
eCTD technical files to enable real-time validation. We will inform industry
stakeholders once this enhancement becomes available.
Industry member, Therapeutic Products
Published:
Regulatory Updates