eCTD submissions

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

eCTD Portal training for Industry

The video recording and slide presentation (including FAQs) of the HSA eCTD portal training for industry held on 28 May 2025 have been published. Please click here .

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.

Training video and  Presentation slides6330 KB for HSA eCTD Portal training (28 May 2025)
  •  HSA Summary of Envelope Requirements106 KB
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    We would like to update industry that Singapore's eCTD system will be available for test submissions in Q3/Q4 2025. Further details regarding the official launch date for actual submissions will be announced subsequently.

    Contact Us

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