ACDM News Item

Regulatory Considerations DMEG to Review Health Canada’s Draft Guidance

Date: August 4, 2026

Thank you to the Regulatory Considerations DMEG for sharing this update.

Health Canada published a Draft guidance on decentralized clinical trials. This is part of Health Canada’s effort to modernize clinical trial regulation to allow for new trial types and designs. The guidance applies to phase I-IV trials involving pharmaceuticals, biologics and radiopharmaceuticals intended for human use. It does not apply to medical devices, natural health projects or foods for special dietary purposes.

The ACDM Regulatory Considerations DMEG will be reviewing the draft guidance and publishing a summary of the points that impact data managers. In the interim you can read the draft guidance here: Health Canada Draft guidance on decentralized clinical trials or download here.

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