Phased implementation of ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) – Notice to stakeholders

November 4, 2026
Our file number: 26-106095-825

Background

As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to adopting and implementing all ICH guidance. We’re informing our partners of how we plan to implement the ICH M11 Guideline: Clinical Electronic Structured Harmonised Protocol (CeSHarP).

The ICH Assembly endorsed the final draft and recommended its implementation on November 19, 2025. This guidance has been developed by an ICH Expert Working Group and has been subject to consultation, in accordance with the ICH process. Implementing this guidance aligns with our ongoing commitment to international harmonization and the modernization of clinical trial oversight in Canada.

ICH M11 establishes a harmonized structure and standardized content for clinical trial protocols to:

improve consistency
facilitate regulatory review
support global drug development

We plan to implement ICH M11 in phases. This will support a smooth transition and give our partners time to adapt their processes and systems.

Learn more:

Phase 1: Document-based implementation

In phase 1, sponsors must submit protocols that align with the ICH M11 guideline using traditional document formats, like PDF or DOCX (Microsoft Word).

This phase will:

support a gradual transition to new digital formats
help us adopt M11 protocol structure and content requirements early
let sponsors and reviewers gain experience with the new protocol format
use existing document preparation and submission processes to ease everyone into the changes

Phase 1 will take effect upon publication of this notice. Sponsors may now begin submitting clinical trial protocols using the ICH M11 harmonized structure and content in PDF or DOCX format.

Phase 2: Structured data implementation

In phase 2, we will begin submitting protocols in structured electronic formats (such as JSON or XML). This is consistent with the long-term vision of ICH M11.

We recognize that this will require additional preparation by both regulators and industry. As such, we’ll only introduce Phase 2 after establishing and communicating appropriate technical specifications, guidance and timelines. We’ll communicate when we expect to move forward with Phase 2 at a later date.

Engagement with partners

Health Canada is committed to working collaboratively throughout the implementation process, with interested parties like:

sponsors
industry associations
technology vendors
contract research organizations

We’ll carry out partner engagement activities that support awareness, readiness and successful adoption of ICH M11 requirements.

As details become available, we’ll provide more information about:

implementation timelines
technical considerations
engagement opportunities

Contact us

Contact Health Canada’s ICH coordinator with:

comments or questions
requests for a French version of ICH M11

Email: ich@hc-sc.gc.ca

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2026-11-06