ECTD submissions

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

Release of SG-HSA eCTD specification package (v 1.0)

We are pleased to inform industry that the eCTD Specification package v 1.0 has been released. This is an updated version of the eCTD package v 0.9 incorporating changes based on feedback received during the industry consultation exercise held in May-June 2023. 

The package and related documents may be downloaded 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.
  • NEW HSA Summary of Envelope Requirements106 KB

    • Contact Us

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