9 February 2026 at 11:00:30
New Draft Guidance Released
Updates to Canada’s Clinical Trial Regulations
Health Canada is proposing major updates to how clinical trials for new drugs are regulated in Canada, aiming to make innovative treatments available faster while keeping participants safe.
The federal health agency launched a public consultation on December 20, 2025, to gather feedback on new Clinical Trials Regulations.
These rules would replace outdated sections in the Food and Drug Regulations and COVID-19 trial rules, covering pharmaceuticals, biologics, radiopharmaceuticals, and cannabis, whether the drugs are already approved or not.
Key changes include:
A risk-based approach to oversight, focusing more effort on higher-risk trials.
Flexible terms and conditions for trials, allowing adjustments throughout the process.
Support for innovative designs, like multi-site trials using approved ethics boards to speed up approvals.
Clear rules on applications, good clinical practices, reporting safety issues, and oversight of third-party providers.
Health Canada also released three draft guidance documents:
Draft guidance on clinical trial applications for sponsors (replaces the existing guidance on CTAs): Covers requirements for submitting applications, including protocol details, participant populations, dosage info, and scientific justification for the trial.
Draft guidance on proposed new Clinical Trials Regulations (GUI-0100): Explains the new stand-alone regulations for drug trials, including sales/import rules, conduct requirements, compliance, and risk-based oversight.
Draft guidance on incorporating sex, gender, and intersectional factors: Provides recommendations for including these factors in trial design, analysis, and reporting to improve data relevance and equity.
The consultation is open until March 20, 2026. Comments can be sent via email to bpsip-bpspiconsultation@hc-sc.gc.ca. It's aimed at trial sponsors, researchers, ethics boards, healthcare pros, patient groups, and the public.
Separately, a related consultation on decentralized clinical trials, where activities happen outside traditional sites using digital tools to boost access, runs until February 21, 2026.
These updates build on 2021 consultations and aim to cut red tape, align with global standards like ICH E6R3 (effective April 2026), and help Canada attract more cutting-edge research.
To read more about the updates please click here.