Federal regulationCanada Gazette, Part IComment Period Closed

GI-2025-51-reg4: Regulations Amending Certain Regulations Relating to Clinical Trials

Sponsoring body: Health, Dept. ofIntroduced December 20, 2025Last checked August 25, 2026

Read the official text on gazette.gc.caOfficial version — Canada Gazette, Part I

What this regulation does

These regulations update a series of existing federal regulations across the Food and Drugs Act, Patent Act, Tobacco and Vaping Products Act, and Cannabis Act to align them with a new standalone Clinical Trials Regulations framework, removing outdated clinical trial provisions and cross-referencing the new rules.

Plain-language summary by Legisail.

Business impact

Compliance

Pharmaceutical companies, natural health product manufacturers, cannabis producers, medical device companies, and vaping product manufacturers conducting or sponsoring clinical trials in Canada will need to comply with the new Clinical Trials Regulations instead of the scattered provisions currently embedded in various regulations. Businesses running drug clinical trials will no longer be governed by the old Division 5 of Part C of the Food and Drug Regulations, which is being repealed and replaced by the new framework. Cannabis licence holders conducting research with human participants will need to understand revised definitions distinguishing clinical trials from non-therapeutic research, which affects how they seek authorization for cannabis sales. The RIAS references the companion Clinical Trials Regulations document for detailed cost and compliance analysis, so specific cost estimates and transition timelines are not available in this amending regulation itself.

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Where this regulation is

Proposed