Health Canada has opened a public consultation seeking feedback on proposed Clinical Trials Regulations. The proposal contemplates decentralized or hybrid trial clinical trial designs for trials involving pharmaceuticals, biologics, and radiopharmaceuticals conducted in humans in Canada.
Draft guidance issued in 2025 provides practical direction across the full clinical trial lifecycle. The guidance also outlines expectations for the use of digital health technologies, including requirements for validation, data security, audit trails, and inspection access.
The guidance acknowledges that decentralization itself invites risks, which ought to be identified and mitigated through study design protocols including contracts, informed consent processes, and quality systems.
Individual comments and critiques about the draft guidance can be provided by email to bp*********************@******gc.ca before February 21, 2026.
To Have Your Say as part of a group submission, send feedback to co*****@*******ap.ca before February 10, 2026
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