Background
eCTD is a standard structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions.
As discussed in our previous alert, the HSA had intended to adopt a phased approach for eCTD implementation in Singapore, with adoption by the industry to be voluntary during the initial rollout.
Launch of the new eCTD portal
Following industry consultations and the release of the eCTD Specification Package version 1.0, the HSA has now launched the eCTD portal for test submissions from 30 September 2025 to 27 March 2026.
The HSA encourages companies to submit test submissions on the eCTD portal for familiarization purposes, noting that all test submissions will not be reviewed and will be deleted from the portal once the testing period ends. Companies will be able to make actual submissions on the eCTD portal from 1 April 2026.
On the eCTD portal, companies can access their eCTD identification and transmit their eCTD packages.
During the testing period, companies should only adopt dummy application numbers for test submissions and should not submit actual applications through the Pharmaceutical Regulatory Information System.
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