eCTD submissions

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

Updated SG-eCTD version 1.1 package for submissions from 1 April 2026

The Therapeutic Products Branch (TPB) would like to update industry that the SG-eCTD version 1.1 package and the accompanying summary of changes from v 1.0 have been published. The package is available for download as a ZIP file.


SG-eCTD version 1.1 will be the official standard for actual eCTD submissions with effect from 1 April 2026. The current SG eCTD v1.0 package will be removed from the HSA website after the test submission period ends on 27 March 2026.  Companies planning to submit their application dossiers via eCTD from April onwards should coordinate with their solution providers to ensure that the necessary technical updates are implemented.

TPB is developing a platform for online access to eCTD technical files to enable real-time validation. We will inform industry stakeholders once this enhancement becomes available. 

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 v1.1

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

Click here for the Summary of Changes for SG-eCTD v1.1

The package includes the following:

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