Singapore Updates Therapeutic Product Registration with eCTD Adoption and CMC Declaration Requirement

Introduction

The Health Sciences Authority (HSA) has introduced regulatory updates related to therapeutic product registration. These updates include the formal adoption of the electronic Common Technical Document (eCTD) format and a new requirement concerning the validity of Chemistry, Manufacturing and Controls (CMC) dossiers at the time of submission.

Adoption of eCTD for Dossier Submission

Starting from 1 April 2026, HSA accepts the eCTD format as an official method for regulatory dossier submissions.

Applicants can submit their dossiers through the eCTD portal using SG-HSA eCTD version 1.1, which serves as the standard format. Supporting technical materials, such as document matrices, submission type matrices, and updated SG-regional stylesheets, are available to facilitate validation and submission.

To assist stakeholders, HSA has also provided supporting resources, including training materials, a Q&A document, and a user manual for the portal.

In parallel, several guidance documents have been revised to incorporate eCTD as a submission option, 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

While alternative submission formats remain acceptable for now, companies are encouraged to move toward eCTD. Future implementation phases will be communicated in advance.

New Requirement for CMC Dossier Declaration

Effective 1 June 2026, applicants must include a formal declaration confirming that the submitted CMC dossier does not contain any known quality defects requiring updates or amendments.

This measure is intended to ensure that all submitted technical information remains current and accurate at the time of submission. It also supports Good Submission Practice by reducing the likelihood of outdated data being included in regulatory dossiers.

Additional details can be found in Chapters C, D, and E of the Guidance on Therapeutic Product Registration in Singapore.

Supporting Regulatory Submissions

The transition to structured submission formats such as eCTD and the introduction of additional documentation requirements highlight the need for careful regulatory planning and dossier preparation.

Support in regulatory submission processes and compliance can be explored here:
https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services

Conclusion

These regulatory updates introduce both the formal use of eCTD submissions and a new declaration requirement for CMC dossiers. Together, they contribute to improving submission accuracy and supporting more efficient regulatory processes in Singapore.

For More information: https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-updates-on-therapeutic-product-registration-(1-april-2026)