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As part of its efforts to modernize clinical trials and enhance transparency (see our previous article), Health Canada has launched a new Clinical Trial Search Portal, replacing the Clinical Trials Database introduced in 2013 and released updated guidance on the registration of clinical trials and public disclosure of results.
The New Portal
The new portal is a bilingual, searchable public tool that provides information on Health Canada-authorized clinical trials involving pharmaceutical, biologic and radiopharmaceutical drugs in humans. It is not a clinical trial registry but provides a summary of each trial and links to international registries for additional information, such as study objectives, participant eligibility and results.
Guidance
The final guidance document sets out Health Canada's expectations for sponsors of clinical trials regulated under the Food and Drugs Act. The guidance outlines expectations of registrations of clinical trials, including when and where to register, as well as the reporting of summary results from those clinical trials, including when and where to report results and what results should be reported. Sponsors are expected to register clinical trials and report summary results through registries that meet World Health Organization (WHO) standards, which promote consistent data collection and validation to ensure high-quality, usable data.
The policy expectations described in the guidance are strongly advised and serve as preparation for stakeholders to develop or improve existing practices before Health Canada mandates clinical trial registration and reporting of summary results by way of regulations.
The guidance applies to sponsors of clinical trials of phases 1-3 for drugs and natural health products and investigational testing of Classes II to IV medical devices.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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