Launch of eCTD Portal for test submissions
HSA is pleased to announce the launch of eCTD Portal for test submission, effective 30 September 2025.
The test submission phase will be open for six months from 30 September 2025 to 27 March 2026. During this period, companies are encouraged to submit test submissions to familiarise themselves with the new system. Please note that all submissions made during this test phase will not be processed for regulatory review and will be removed from the system upon completion of the test period. Actual dossier submission in eCTD format will be accepted from 1 April 2026 onward.
You may access the eCTD portal here to obtain your eCTD identification (eCTD ID) and transmit your eCTD packages. To support users in navigating the new system effectively, HSA has prepared comprehensive resources, including the training presentation, Q&A document and a portal user manual.
For test submission, please use dummy application numbers only. No actual applications should be submitted through PRISM during this test phase.
HSA extends its sincere appreciation to the industry for your patience and invaluable feedback throughout the development process. The partnership with industry stakeholders has been instrumental in developing this system. We look forward to receiving dossier submissions through the eCTD portal moving forward.
Subscribe to the HSA announcements page here or visit the eCTD webpage to keep up to date with the latest eCTD developments.
Industry member, Therapeutic Products
Published:
Regulatory Updates