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2 March 20231 minute read

Consultation on Health Canada’s transparency of clinical trials - draft guidance and public search ‎portal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 Stakeholder feedback was used to develop a draft guidance document on the registration ‎and public disclosure of clinical trial results.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Consultation on the draft guidance document and proposed mock-ups is open until April 24, 2023.‎

For more information related to Health Canada’s consultation, please do not hesitate to contact Nicole ‎Nazareth or Geoff Mowatt with inquiries.‎