Should Canada Modernize Its Clinical Trial Rules?

Official title: Consultation: Modernizing the framework for clinical trials

Open Regulations & Permits Health & Safety

Health Canada wants to overhaul how drug trials are approved and monitored. The current rules date back decades and don't reflect modern research practices. The proposed changes would create a risk-based system—simpler requirements for low-risk trials, stricter oversight for high-risk ones. This could speed up access to new treatments while keeping participants safe.

Why This Matters

Waiting for a new cancer drug or treatment for a rare disease? Clinical trials are how those treatments get tested before they reach you. Faster, smarter trial approvals could mean new therapies arrive sooner. If you've ever considered joining a clinical trial, these rules affect your safety protections too.

What Could Change

Low-risk trials could get approved faster with less paperwork. A new list of approved ethics boards would streamline multi-site trials across Canada. Third-party companies running trials would face direct government oversight for the first time. Sponsors could receive 'contingent authorizations' allowing trials to proceed while meeting conditions.

Key Issues

Should clinical trials use a risk-based approach with simpler rules for low-risk studies?
Should there be a national list of approved ethics boards to speed up multi-site trial approvals?
Should third-party service providers running trials face direct regulatory oversight?
Are the draft guidance documents clear enough to support compliance?

How to Participate

To comment on the proposed regulations, submit through the Canada Gazette, Part I.
To comment on the draft guidance documents, use the online feedback form or email bpsip-bpspiconsultation@hc-sc.gc.ca.
Review the draft guidance on clinical trial applications, SGBA+ demographics guidance, and GUI-0100 guidance before providing feedback.

Submit Your Input

Comment On Proposed Regulations Via Canada Gazette Provide Feedback On Draft Guidance Documents Draft Email

Email Template

Dear Bureau of Policy, Science and International Programs,

I am writing regarding the consultation on modernizing the framework for clinical trials.

I [support / oppose / have concerns about] the proposed changes because:
[Your reason - even one sentence counts]

How this affects me:
[Your connection to clinical trials - patient, researcher, healthcare provider, etc.]

On the clarity of guidance documents:
[Are they clear and easy to understand?]

On compliance support:
[Do they provide enough detail? What resources would help?]

Areas needing clarification:
[Any aspects that should be clearer?]

Impact on practices:
[How will this affect your organization or work?]

Thank you for considering my feedback.

Sincerely,
[Your name]

Questions Being Asked (5)

Is the information clear and easy to understand?
Do the guidance documents provide enough details to support compliance?
Are there areas that should be clarified?
Are there resources and supports that would help your organization implement the guidance more effectively (for example, tools, templates, graphics)?
How will the proposed approach impact your organization or practices?