Singapore HSA Implements CMC Declaration Requirement Following eCTD Adoption

On June 1, 2026, Singapore’s Health Sciences Authority (HSA) implemented a new Chemistry, Manufacturing and Controls (CMC) declaration requirement for therapeutic product registration applications. The requirement forms part of a broader regulatory update announced on April 1, 2026, which also introduced the official acceptance of the electronic Common Technical Document (eCTD) format for dossier submissions.

CMC Declaration Requirement Now Applies to New Submissions

The HSA now requires applicants to include a declaration letter with therapeutic product registration submissions confirming that:

• No known quality defects exist for the product; and
• No amendments or updates are required to the submitted CMC package at the time of submission.

The declaration reinforces applicant responsibility for ensuring that the submitted CMC dossier accurately reflects the product, manufacturing, and quality information at the point of submission.

To reinforce Good Submission Practice, the requirement aims to:

• Improve dossier quality by minimizing the submission of outdated or superseded technical information
• Support more effective assessment of product quality information and enhance regulatory review efficiency

The measure reinforces expectations that applicants maintain effective internal controls over regulatory documentation and lifecycle management activities.

While the new declaration requirement focuses on the quality and integrity of submitted data, HSA's April 2026 regulatory update also introduced a significant change to how dossiers may be submitted.

HSA Now Accepts eCTD Dossier Submissions

HSA now accepts regulatory dossier submissions in eCTD format through its eCTD portal using SG-HSA eCTD Version 1.1, which serves as the authority’s official standard for eCTD submissions.

While existing non-eCTD submission pathways remain available during the current implementation phase, applicantsare encouraged to transition to eCTD. HSA has indicated that future implementation phases will be announced in advance.

Resources Available to Support eCTD Implementation

To support dossier preparation and validation, HSA has made several technical resources available online for real-time access, including:

• Defined lists
• Document matrix
• Submission type matrix
• Updated SG-regional stylesheet

These resources are intended to facilitate accurate dossier compilation and validation in accordance with HSA requirements.

In addition, HSA has published supporting implementation materials, including:

• Training presentations
• Frequently asked questions (Q&A) documents
• Portal user manuals

Applicants should continue monitoring the HSA eCTD webpage for future implementation updates and additional guidance.

Updated Guidance Documents

HSA has revised several guidance documents to incorporate eCTD as an accepted regulatory dossier submission format, including:

• "Guidance on Therapeutic Product Registration in Singapore"
• "Appendix 2A: Application Checklist (ICH CTD_NDA_GDA)"
• "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"

Final Thoughts

HSA’s latest therapeutic product registration updates reflect a continued focus on digitalization, submission quality, and regulatory data integrity. The acceptance of eCTD submissions establishes a more structured electronic framework for regulatory filings, while the new CMC declaration requirement reinforces applicant accountability for the accuracy, completeness, and currency of submitted quality information.

Companies should review these updates carefully and ensure that dossier preparation processes, CMC lifecycle management, and submission procedures are aligned with the revised HSA requirements.

Reference

Health Sciences Authority (HSA), "Regulatory Updates on Therapeutic Product Registration (1 April 2026)."

‍