ECTD submissions

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

Update on the release date of eCTD specification package (v 1.0) and implementation

We wish to inform stakeholders that the timeline for releasing the eCTD specification package (version 1.0) has been adjusted to Q3 2024 according to the system testing schedules. Additional testing is required to ensure the functionality and smooth transition to the eCTD platform. To allow sufficient time for stakeholders to familiarise with version 1.0, the target eCTD implementation date has been revised to Q1 2025.


HSA will provide regular updates on the progress of eCTD implementation, and we seek your understanding on the unforeseen delay. We will work closely with our industry stakeholders to ensure a successful deployment of the eCTD system.


To assist industry stakeholders who are new to eCTD submissions, we have prepared some tips for selecting an eCTD software vendor to facilitate the company’s transition to eCTD.

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. 

Further guidance on eCTD submissions will be published closer to the target implementation date (estimated Q1 2025). Bookmark this page for the latest updates or subscribe to HSA announcements.    

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.

Download the package as a ZIP file: SG-HSA Specification Components (806KB)


 

Download the package as a ZIP file: SG-HSA Validation Components (96 KB) (updated 9 May 23)





Contact Us

For more information on eCTD submissions, please email us at HSA_TP_ectd@hsa.gov.sg 

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