Health Canada's Clinical Trials Regulatory Modernization Initiative
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. Modernization of the regulations will introduce a coherent risk-based approach, afford greater flexibility in the safe development of innovative therapies, streamline processes toward greater efficiency and clarity, and align with international best practices regarding oversight and public access to information.
Health Canada identified this regulatory initiative in the
Health and Biosciences Sector Regulatory Review Roadmap
. This regulatory modernization initiative for clinical trials is also listed under
Health Canada Forward Regulatory Plan
Health Canada has posted a
for public comment outlining several wide-reaching proposals for the modernization of Canada’s clinical trials regulatory regime. Health Canada will use stakeholder feedback received as part of this consultation to validate and inform further policy and will continue to engage stakeholders moving forward.
Interested stakeholders will have the opportunity to provide feedback on this consultation made available on May 20, 2021 for a period of 45 days until July 4, 2021. For any questions regarding this consultation, please contact Health Canada’s Bureau of Policy, Science and International Programs at the following email:
Please note that you must
on the last page of the questionnaire for your input to be considered.
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