Health Canada implementation of the ICH E6(R3) guideline: Notice to stakeholders
October 17, 2025
Our file number: 25-105890 – 674
As a Standing Regulatory Member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. Health Canada is announcing the planned implementation of the ICH E6(R3) guideline on Good Clinical Practice (GCP), effective April 1, 2026. The ICH Assembly endorsed the final draft and recommended its implementation on January 6, 2025. This guidance has been developed by the appropriate ICH Expert Working Group (EWG) and has been subject to consultation, in accordance with the ICH Process. This implementation aligns with Health Canada's ongoing commitment to international harmonization and the modernization of clinical trial oversight in Canada.
The ICH E6(R3) guideline represents a significant evolution in the principles and practices of GCP, emphasizing a more flexible, risk-based approach to clinical trial design, conduct, oversight, and documentation. It aims to enhance data integrity and participant safety while supporting innovation in clinical research.
To support a smooth transition, Health Canada is providing a preparatory period of six months. This period is intended to allow stakeholders—including sponsors, service providers, investigators, and institutional review boards—to:
- conduct comprehensive training on the new guideline requirements
- review and revise internal standard operating procedures (SOPs)
- update quality management systems and documentation practices, and
- align ongoing and planned clinical trials with the new expectations
As part of this implementation, Health Canada expects sponsors to clearly identify Critical to Quality Factors with their associated risks and mitigation measures in their protocols.
Health Canada encourages all stakeholders to begin preparations promptly to ensure full compliance by the implementation date. Additional guidance, training resources, and stakeholder engagement opportunities will be made available in the coming months.
This and other ICH Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the ICH Coordinator inbox.
For further information or to access the ICH E6(R3) guideline, please visit the Health Canada ICH Guidelines page.
For inquiries, contact:
Health Canada – ICH Coordinator
Email: ich@hc-sc.gc.ca