On July 29, 2026, Health Canada launched a new Clinical Trials Search Portal and released its Guidance on the Registration of Clinical Trials and Public Disclosure of Results, providing the public with greater access to information about clinical trials authorized in Canada.[1]
While not currently legally binding, the guidance sets clear expectations for clinical trial registration and results disclosure and signals Health Canada’s broader push for transparency in clinical research. Health Canada describes this policy-first approach as a way to allow sponsors to adapt before potential regulatory requirements are introduced. For sponsors conducting clinical trials in Canada, the announcement therefore represents more than the launch of a new public-facing tool, it provides an indication of the direction of Canada’s evolving clinical trial framework.
Who does the Guidance Apply to?
The guidance applies to sponsors of clinical trials regulated under the Food and Drugs Act and its regulations, including:
- phase 1 to phase 3 drug clinical trials;
- phase 1 to phase 3 natural health product clinical trials; and
- investigational testing involving Class II, III and IV medical devices.
The guidance does not apply to:
- Comparative bioavailability studies;
- Open label individual patient (“OLIP”) trials;
- Phase IV drug and natural health product trials conducted within the terms of their marketing authorization; and
- Clinical trials involving Class I devices and licensed devices used within the terms of their marketing authorization.
Key Expectations Under the New Guidance
Registration of Clinical Trials
- Sponsors are expected to register clinical trials in a publicly accessible registry that complies with World Health Organization (“WHO”) standards, such as ClinicalTrials.gov.
- Registration should occur ideally before enrolment opens in Canada and, in any event, no later than 21 calendar days after enrolment of the first participant, with the date on which registration materials are first submitted treated as the registration date.
- For multinational studies that include Canadian sites, sponsors are expected to add the Canadian site(s) to the existing registry record on the same timeline, namely no later than 21 calendar days after enrolment of the first participant at the Canadian site(s).
Public Disclosure of Summary Results
- Sponsors are expected to submit summary results to the same registry in which the clinical trial was registered, generally within 12 months following primary study completion, which is defined as the final study visit for collection of data relating to the primary outcome measure for the last participant in the global study.
- Where a sponsor intends to seek market authorization for the studied product or a new condition of use, disclosure may be deferred until the earlier of (i) 30 calendar days after Health Canada renders a decision on the market authorization application (or the sponsor withdraws or cancels that application), or (ii) 36 months following primary study completion. That said, deferral is not available for trials of products, or new conditions of use, that the sponsor does not intend to market or for which development has been discontinued.
Maintenance of Registry Information
- Sponsors are expected to keep clinical trial information current, including updating trial status and submitting outstanding summary results information where applicable. The guidance also recommends that protocol codes be used consistently across Health Canada submissions and registry records to facilitate identification and matching of trials.
New Clinical Trial Search Portal
Alongside the guidance, Health Canada launched the Clinical Trial Search Portal. Health Canada emphasizes that the portal is not a clinical trial registry, but rather a public search tool intended to facilitate access to information regarding Canadian clinical trials.
The portal replaces the former Clinical Trials Database and, where available, includes information obtained from Health Canada-authorized clinical trial applications and international registries. It also provides links to registry records where users can access additional information about the clinical trial, including publicly available summary results.
Initially, the portal will publish information relating to certain drug clinical trials, including pharmaceutical, biologic and radiopharmaceutical trials that meet the same eligibility criteria as those previously included in the former Clinical Trials Database.
Key Implications for Stakeholders
The guidance is directed at sponsors, but it carries practical implications across the clinical research ecosystem, including CROs and academic research institutions, as outlined below.
Since the guidance addresses registration as well as ongoing registry maintenance and public disclosure of results, sponsors should assess whether their compliance frameworks can support these expectations across the full life cycle of a trial, including registration records, study status updates and results reporting.
As the portal draws on both Health Canada submissions and international registries, stakeholders should ensure the information they submit across platforms is accurate, complete and consistent. Although Health Canada frames this guidance as a “policy-first approach” rather than a legal requirement, the guidance signals its expectations on clinical trial transparency. Sponsors should review whether their registration, registry maintenance, results reporting and governance practices align with the framework and can adapt to future regulatory requirements.
