Review of the Regulatory Framework for Clinical Trials
On September 1, 2001, the regulatory amendments to Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects) came into force, with two overarching objectives:
- to strengthen protections for clinical trial subjects; and
- to attract and sustain investment in research and development in Canada.
Health Canada initiated a review of the clinical trials regulatory framework in 2006 with stakeholder consultations in the summer of 2006 and spring of 2007 to inform the development of measures to improve the clinical trials regulatory framework. Summary documents from these consultations are available in the documents and reports section of this website.
Health Canada officials have assessed the input received from stakeholders, considered best practices in other countries, as well as Health Canada's experience with the existing regulatory framework. The Clinical Trials Regulatory Review: Targeted Measures for a Strengthened Framework outlines a series of initiatives that Health Canada will undertake to further support the objectives of strengthening the protection of clinical trial subjects, and attracting and sustaining investments in research and development in Canada.
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