Federal regulationCanada Gazette, Part IComment Period Closed
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Products Act, and Cannabis Act to align them with a new standalone Clinical Trials Regulations framework, removing outdated clinical trial provisions and cross-referencing the new rules.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trials will no longer be governed by the old Division 5 of Part C of the Food and Drug Regulations, which is being repealed and replaced by the new framework.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.
Does this apply to you?
Your own business or clients you watch for — tell Legisail what matters and it checks every bill and regulation against it.
Where this regulation is
Proposed
Comment period closed
Final publicationPending
Legisail watches this for you
Tell Legisail about your business and it checks every new bill and regulation against it — you only hear about the ones that matter.
Create a free accountFree · 30 seconds · No credit card