eCTD Format Acceptance and Quality Defect Declaration Requirements for Therapeutic Products

HSA Singapore Announcements

Published March 31st, 2026

Detected April 1st, 2026

Summary

HSA Singapore announced that electronic Common Technical Document (eCTD) format will be officially accepted for therapeutic product regulatory dossier submissions effective 1 April 2026, using SG-HSA eCTD version 1.1. Additionally, applicants must provide an official declaration confirming no known quality defects in CMC dossiers for submissions from 1 June 2026 onward.

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What changed

HSA Singapore has introduced two regulatory enhancements for therapeutic product registration. First, eCTD format becomes officially accepted starting 1 April 2026, with companies required to use SG-HSA eCTD version 1.1 through the dedicated portal. Multiple guidance documents including the main Guidance on Therapeutic Product Registration and Appendices 2A, 2B, 5, 11, 13, 14, and 17 have been updated to reflect eCTD as a dossier submission option. Second, effective 1 June 2026, applicants must submit an official letter declaring no known quality defects that would require amendments to the CMC package at the point of submission.

Companies submitting therapeutic products to HSA should prepare to transition to eCTD v1.1 format by 1 April 2026 by accessing technical files, validation tools, and the updated sg-regional stylesheet from the eCTD webpage. For submissions from 1 June 2026 onward, applicants must establish internal processes to issue quality defect declaration letters confirming CMC dossier validity. While non-eCTD submissions remain permitted for now, companies are strongly encouraged to transition to eCTD. No penalties are specified in the announcement.

What to do next

Prepare IT and regulatory systems for eCTD v1.1 submissions using SG-HSA eCTD version 1.1 portal by 1 April 2026
Develop process for issuing quality defect declaration letters for CMC dossiers by 1 June 2026
Review updated HSA guidance documents including Appendices 2A, 2B, 5, 11, 13, 14, and 17

Source document (simplified)

Regulatory Updates on Therapeutic Product Registration (1 April 2026)

1. eCTD format officially accepted for regulatory dossier submission

HSA is pleased to announce that electronic Common Technical Document (eCTD) format will be officially accepted for regulatory dossier submission with effect from 1 April 2026.

Companies may submit eCTD packages for actual dossiers through the eCTD portal using SG-HSA eCTD version 1.1, which serves as the official standard for all eCTD submissions. The technical files for defined lists, document matrix and submission type matrix are available online for real-time access and validation, along with an updated sg-regional stylesheet.

To support users in navigating the new system effectively, HSA has prepared the necessary resources, including the training presentation, Q&A document and a portal user manual.

In addition, HSA has updated the following guidance documents to include eCTD as a dossier submission option.

Guidance on Therapeutic Product Registration in Singapore
Appendix 2A: Application checklist (ICH CTDNDAGDA)
Appendix 2B: Application Checklist (ICH CTD – MAV)
Appendix 5: Target Processing Timeline
Appendix 11: Guideline on Drug Master File
Appendix 13: Guideline on MIV Applications for Chemical Therapeutic Products
Appendix 14: Guideline on MIV Applications for Biological Therapeutic Products
Appendix 17: Guideline on PRISM Submission Companies may continue with their current non-eCTD submission modes but are strongly encouraged to transition to eCTD. HSA will provide advance notice before any subsequent phases of the roll-out.

Please visit the eCTD webpage to keep up to date with the latest eCTD developments.

2. Declaration of quality defects to ensure Chemistry, Manufacturing & Controls (CMC) dossier remains valid at the point of submission

To promote Good Submission Practice and better support applicants to ensure that the CMC dossier remains valid at the point of submission, applicants will be required to provide an official letter declaring that there are no known quality defects that would require amendment or updates to the submitted CMC package, with effect from 1 June 2026. This enhancement aims to minimise inadvertent submission of superseded technical data and improve regulatory efficiency.

Refer to Chapters C, D and E of the Guidance on Therapeutic Product Registration in Singapore for more information.

Industry member, Therapeutic Products Published:

31 Mar 2026

Regulatory Updates

31 Mar 2026