Consultation: Modernizing the framework for clinical trials
Current status: Open
Opened on December 20, 2025, and will close to new input on March 20, 2026.
Health Canada is seeking 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.
Join in: How to participate
You can provide your feedback in the following ways:
- To comment on the proposed regulations, submit your comments through the Canada Gazette, Part I.
- To comment on the 3 draft guidance documents in the table related to this proposal:
- use the online stakeholder feedback form or
- send an email to bpsip-bpspiconsultation@hc-sc.gc.ca
- In the subject line, use: "Modernizing the framework for clinical trials – Guidance consultation comments".
- Submit 1 letter that summarizes your key feedback.
- Include any detailed comments on specific guidance documents in an annex to your submission.
- Be sure to copy (cc) the appropriate directorate that corresponds to the guidance document you are commenting on.
| Guidance document | New guidance or update to existing guidance | Contact |
|---|---|---|
| Draft guidance on clinical trial applications for clinical trial sponsors | Update | Pharmaceutical Drugs Directorate, Health Products and Food Branch: bpsip-bpspiconsultation@hc-sc.gc.ca |
| Draft guidance document for clinical trial sponsors: Sex and gender-based analysis (SGBA) plus demographics action plan in clinical trial applications | New | Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch: brdd-cppic_brdd-cppci@hc-sc.gc.ca |
| Draft guidance on proposed new Clinical Trials Regulations (GUI-0100) | Update | Medical Devices and Clinical Compliance Directorate, Regulatory Enforcement and Operations Branch: GUI100Consultation@hc-sc.gc.ca |
The deadline for feedback is March 20, 2026.
Who is the focus of this consultation
We are seeking comments from:
- industry, academic and institutional clinical trial sponsors
- industry associations
- research ethics boards
- health system partners
- health care professionals
- patient safety and advocacy groups
- public
Key questions for discussion
Your comments on the proposed regulations should be submitted through the Canada Gazette, Part I. Consider the following themes:
- overall authorization scheme of the overall conduct of clinical trials, including the issuance of a contingent authorization
- risk-based approach to regulatory requirements (pre- and post-authorization)
- list of approved national research ethics boards, which would help to streamline the approval process for multi-site trials
- terms and conditions to support a more agile and risk-based approach to regulating clinical trials over their lifecycle
- direct regulatory oversight over third-party service providers who conduct trials or parts of a trial for a sponsor
When you provide your feedback on the draft guidance documents using the online questionnaire or by email, ask yourself:
- 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?
We will use the feedback we receive to refine the draft guidance documents and the Clinical Trial Regulations for drugs.
What we are hearing
After the consultation closes, we will publish an interim "What we heard" report on the key feedback and themes received.
Related links and 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