Stakeholder Consultation – Modernizing Health Canada’s Clinical Trials Framework

Posted Date: 8-June-2021

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Health Canada will be hosting a webinar on June 22 to provide information regarding the Clinical Trials Modernization Initiative as it relates to clinical trials for health products.

Health Canada launched a consultation paper and an accompanying questionnaire for the Clinical Trials Regulatory Modernization Initiative on May 20, 2021. The consultation paper introduces several wide-ranging proposals for transforming Canada’s regulatory framework for clinical trials related to human drugs, medical devices, and natural health products. The proposals are intended to meet several key policy objectives, including the provision of proportional risk-based oversight; new regulatory agilities over the lifecycle of the trial; greater transparency through registration and public disclosure of results; and a modernized and expanded compliance and enforcement regime.

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