Should Canada Update Its Rules for Drug Clinical Trials?

Official title: Consultation: Modernizing the framework for clinical trials

Open Regulations & Permits Health & Safety
Health Canada wants to overhaul how drug clinical trials are approved and monitored. The current rules date back decades. The proposed changes would create a risk-based system—lighter oversight for low-risk trials, stricter rules for higher-risk ones. The goal? Get promising treatments to patients faster while keeping trial participants safe.

Why This Matters

Waiting for a new treatment that's stuck in trials? These rules affect how quickly new drugs reach Canadian patients. If you've ever considered joining a clinical trial, the safety protections in these regulations apply to you. Faster approvals could mean earlier access to innovative therapies for serious conditions.

What Could Change

The proposed regulations would replace current clinical trial rules under the Food and Drug Regulations. A new risk-based system would mean faster approvals for low-risk trials and stricter oversight for higher-risk ones. Third-party companies running trials would face direct Health Canada regulation for the first time. A national list of approved ethics boards could speed up multi-site trial approvals.

Key Issues

  • Should clinical trials use a risk-based approach with lighter rules for low-risk trials?
  • Should Health Canada create a list of approved national research ethics boards to streamline multi-site trials?
  • Should third-party service providers who run trials be directly regulated?
  • Are the draft guidance documents clear enough to support compliance?

How to Participate

  1. To comment on the proposed regulations, submit through the Canada Gazette, Part I.
  2. To comment on the draft guidance documents, use the online stakeholder feedback form.
  3. Alternatively, email your feedback on guidance documents to bpsip-bpspiconsultation@hc-sc.gc.ca with subject line: "Modernizing the framework for clinical trials – Guidance consultation comments".

Submit Your Input

Comment On Proposed Regulations Provide Feedback On Guidance Documents Draft Email
Questions Being Asked (9)
  1. What are your views on the overall authorization scheme for clinical trials, including contingent authorization?
  2. What do you think of the risk-based approach to regulatory requirements?
  3. Do you support a list of approved national research ethics boards to streamline multi-site trials?
  4. What are your views on direct regulatory oversight of third-party service providers?
  5. Is the information in the guidance documents clear and easy to understand?
  6. Do the guidance documents provide enough details to support compliance?
  7. Are there areas that should be clarified?
  8. What resources would help your organization implement the guidance more effectively?
  9. How will the proposed approach impact your organization or practices?

Key Documents