Consultation: Health Canada's Clinical Trials Regulatory Modernization Initiative
Current status: Open
Opened on May 20, 2021 and will close to new input on July 4, 2021.
As part of the Health and Biosciences Sector Regulatory Review Roadmap, Health Canada is proposing to modernize the regulatory framework for clinical trials related to human drugs, medical devices, non-prescription drugs, and natural health products. Health Canada is launching a consultation paper alongside a questionnaire to seek feedback from interested stakeholders to validate and inform further policy development.
Join in: how to participate
We invite you to read the consultation paper , which outlines key policy proposals for the modernization of Canada's clinical trials regulatory framework.
Using the consultation paper as a guide, you can provide your feedback in the following ways:
Who is the focus of this consultation?
Health Canada is seeking feedback from industry and non-industry stakeholders, including all interested Canadians.
Goals of the consultation
Health Canada is seeking feedback on the Clinical Trials Regulatory Modernization Initiative. The feedback received during the consultation will be used to better inform decision-making with respect to outstanding proposed regulatory, policy, and program considerations for each of the product lines.
Health Canada has prepared a consultation paper and an online questionnaire to seek your feedback on key themes of the initiative, including:
- Agile lifecycle approach
- Risk-based approach
- Use of new authorities – terms and conditions
- Compliance and enforcement approach
The consultation paper and online questionnaire includes human drugs, medical devices, non-prescription drugs, and natural health products.
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Ottawa, ON K1A 0K9
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