Consultation on Health Canada’s transparency of clinical trials - draft guidance and public search portal
In 2021, Health Canada held a consultation on its proposal to modernize the clinical trials regulatory framework. Stakeholder feedback was used to develop a draft guidance document on the registration and public disclosure of clinical trial results.
Health Canada has now released this proposed guidance document for consultation, detailing policy expectations for sponsors of authorized clinical trials investigating drugs (pharmaceutical, biologic and radiopharmaceutical), medical devices, and NHPs. Health Canada has stated that this policy should give sponsors time to adjust to the process for registration of trials and reporting results using international registries, before regulations are proposed in Canada.
Health Canada is also building a search portal to replace the existing Clinical Trials Database, and is seeking feedback on proposed mock-ups of such a portal:
• Mock-up 1
• Mock-up 2
• Mock-up 3
• Mock-up 4
Consultation on the draft guidance document and proposed mock-ups is open until April 24, 2023.