Consultation: Registration of Clinical Trials and Public Disclosure of Results: Draft Guidance and Public Search Portal

From Health Canada

Current status: Closed

This consultation ran from February 23, 2023 to April 24, 2023.

Health Canada has developed a draft guidance document and is proposing a clinical trials search portal. This portal would help make more Canadian authorized trial information available to the public and improve accessibility of this information.

Health Canada is seeking your feedback on:

Who was the focus of this consultation

We engaged with:

Goals of the consultation

Health Canada is committed to improving the transparency of Canadian clinical trial information. This consultation advances priority work under the Department's Forward Regulatory Plan for 2022-2024 to modernize the clinical trials regulatory framework.

In spring 2021, Health Canada held a consultation on its proposed Clinical Trials Regulatory Modernization Initiative to gather feedback from stakeholders. A description of the transparency proposals was included. Stakeholder feedback has informed the development of the draft guidance document and proposed public search portal.

The draft guidance outlines Health Canada's policy expectations for sponsors of authorized clinical trials investigating drugs (pharmaceutical, biologic and radiopharmaceutical), medical devices and NHPs. 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.

To complement this work and improve public accessibility, Health Canada is building a search portal to replace the existing Clinical Trials Database. All Canadian authorized clinical trials would be included, with phased implementation. During the first phase of the portal, the department will publish information about authorized drug trials. Future phases will include information about trials investigating medical devices and NHPs.

Consultation: Health Canada's Clinical Trials Regulatory Modernization Initiative

Forward Regulatory Plan 2022-2024: Modernization of the Regulation of Clinical Trials

Key questions for your input

Ideas and inputs were sought around 3 themes/topics:

The input that was gathered through this process will be used to:

Related information

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1Y 4N7


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