eCTD submissions

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

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.


Login to eCTD portal  


Please click here for other eCTD resources. Should you need further clarification on test submissions, please contact us at HSA_TP_eCTD@hsa.gov.sg

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. 

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eCTD specification package 1.0

The latest version of the SG-HSA Specification package must be used for eCTD submissions to HSA upon implementation.

Resources for Industry



Selecting the right eCTD vendor is essential for efficient regulatory documentation management and submission. Some key factors to consider include:

  • Compliance and Standards: Ensure the vendor's software complies with regulatory standards, including ICH specifications for eCTD.
  • User-Friendly Interface: An intuitive, easy-to-navigate interface enhances efficiency in document management and submission processes.
  • Technical Support and Training: Evaluate the vendor's support services and training resources.
  • Integration Capabilities: Check if the software can integrate with existing systems.
  • Scalability: Assess if the solution can accommodate increasing document volumes and adapt to new regulatory requirements.
  • Security and Data Protection: Ensure the vendor has robust security measures to protect sensitive data and maintain data integrity.
  • Cost: Evaluate the overall cost-effectiveness of the software
  • Reputation and Experience: Consider the vendor’s reputation and experience in regulatory submissions among major regulatory agencies.
  • Trial and Demo: Request a demo or trial period to assess how well the software meets your needs. Sample submissions provided in this website may be used for demo/trial purposes.


Contact Us

Technical helpdesk for eCTD portal: eCTD_helpdesk@hsa.gov.sg
For general enquiries, please email us at HSA_TP_ectd@hsa.gov.sg