Closed consultation: Modernizing the framework for clinical trials
Current status: Closed
This consultation ran from December 20, 2025 to April 19, 2026.
Health Canada held a public consultation on the proposed Clinical Trials Regulations and associated guidance documents following prepublication in the Canada Gazette, Part I, from December 20, 2025 to April 19, 2026.
Who was the focus of this consultation
We engaged with:
- industry, academic and institutional clinical trial sponsors
- industry associations
- research ethics boards
- health system partners
- health care professionals
- patient safety and advocacy groups
- public
Goals of the consultation
Health Canada sought feedback on the proposed Clinical Trials Regulations for drugs (pharmaceuticals, biologics and radiopharmaceuticals) and on multiple guidance documents related to the proposal. The proposed framework would replace the clinical trial regulatory schemes for drugs in the following sections of the regulations:
- Part C, Division 5 of the Food and Drug Regulations and
- Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
This proposed framework aims to improve access to new and innovative therapies for people in Canada while maintaining strong safety protections for participants.
This initiative is part of Health Canada and the Public Health Agency of Canada's work to streamline processes and enhance regulatory efficiency.
These are outlined in the Red Tape Reduction Report.
We will consider all input and feedback received before finalizing the regulatory framework and guidance documents.
Key questions for discussion
Ideas and inputs were sought around the following themes:
- the overall authorization scheme of the overall conduct of clinical trials, including the issuance of a contingent authorization
- the risk-based approach to regulatory requirements (pre- and post-authorization)
- the list of approved national research ethics boards, which would help to streamline the approval process for multi-site trials
- the terms and conditions to support a more agile and risk-based approach to regulating clinical trials over their lifecycle
- the direct regulatory oversight over third-party service providers who conduct trials or parts of a trial for a sponsor.
We will use the feedback we receive to refine the draft guidance documents and the Clinical Trials Regulations for drugs.
What we heard
A "What we heard" report on the key feedback and themes received will be published.
Related information
Existing guidance documents:
- Guidance document for clinical trial sponsors: clinical trial applications
- Guidance document: part c, division 5 of the food and drug regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100)
Other:
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: bpsip-bpspiconsultation@hc-sc.gc.ca