New guidance and public search portal for clinical trials approved in Canada: Notice
Our file number: 26-104462-113
July 29, 2026
On this page
What we did
Health Canada has a new guidance on registering clinical trials and disclosing the results as well as a new public search portal for clinical trials that are regulated under the Food and Drugs Act (act). This work is part of our efforts to modernize clinical trials in Canada and demonstrates our commitment to making information on clinical trials more transparent.
We consulted with stakeholders between February 23 and April 24, 2023, on the draft for the guidance document and mock-ups of the search portal. The comments helped to inform the final guidance document and search portal, and are captured in a “what we heard” report.
About the guidance document
The final guidance document outlines the policy expectations for sponsors of Canadian clinical trials that are regulated under the act. Sponsors are to register and report their summary results using registries that comply with World Health Organization standards. The standards ensure that registry owners collect and validate data in the same way. This contributes to data that are useable and of good quality.
This guidance document applies to all sponsors of clinical trials that are regulated under the act and its regulations, including:
- clinical trials for phases 1 through 3 of drug development
- clinical trials for phases 1 through 3 of natural health product development
- clinical trials (also known as investigational testing) for Classes II to IV medical devices
This guidance document does not apply to:
- comparative bioavailability studies
- clinical trials designed as single patient trials, also known as open label individual patient (OLIP) trials
- clinical trials for phase 4 development of drugs and natural health products used according to the terms of their marketing authorization
- clinical trials involving Class I devices and licensed devices used according to the terms of their marketing authorization
This policy-first approach makes it possible for clinical trial sponsors to develop or update existing practices on registering trials and reporting the results before Health Canada would step in and propose any regulatory requirements.
About the search portal
The search portal is not a registry, but a search tool. It’s designed to help the public easily access information on Canadian clinical trials.
When Health Canada finds a clinical trial approved by us in a registry, we use advanced automation technologies to extract some of the information for the portal. The information published in the portal is in a bilingual, searchable format and includes weblinks to the registry where people can find the full clinical trial record.
Initially, the search portal will publish information for drug clinical trials (pharmaceutical, biologic, radiopharmaceutical) that meet the same criteria as the trials on our Clinical Trials database, which we launched in 2013.
Learn more:
- Guidance on the registration of clinical trials and public disclosure of results
- The clinical trials search portal
- Consultation on the draft guidance and search portal
- What we heard: Consulting on new policy and search portal to make clinical trial information more transparent
- Clinical trials modernization
Contact us
Contact us by mail or email if you have questions about the guidance document and portal:
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St
6th Fl, Holland Cross, Tower B
Ottawa ON K1A 0K9
Mail stop 3106C
Email: ct.portal.team-equipe.portail.ec@hc-sc.gc.ca