Health Canada launches new public search portal and updated guidance for clinical trials

Health Canada has announced the launch of a new public search portal for clinical trials that are authorized in Canada and regulated under the Food and Drugs Act (the Act), together with updated guidance documents for clinical trial applicants and sponsors. These changes represent a significant step toward greater transparency in Canada’s clinical trial regulatory framework and will have practical implications for life sciences companies, clinical trial sponsors, and contract research organizations operating in Canada¹.

What you need to know

• Health Canada has launched a publicly accessible Canadian Clinical Trial Search Portal that allows patients, researchers, and industry stakeholders to search for information about clinical trials that Health Canada has authorized. This includes information on clinical trials conducted in Canada taken from Health Canada’s data management systems as well as from international registries and the World Health Organization’s International Clinical Trials Registry Platform².
  • A guidance document has been published to clarify the expectations for sponsors of clinical trials, including in respect of registration and submissions of summary results.
• The portal enhances transparency by making information about authorized clinical trials more readily accessible, aligning Canada’s approach with international practices.
• Clinical trial sponsors and contract research organizations should review their current processes and documentation to ensure they are aligned with the new guidance, particularly regarding information that will now be publicly available through the portal.  
• Stakeholders should consider the confidentiality and competitive implications of clinical trial information being publicly available and ensure that clinical trial authorization submissions are complete and accurate given their increased visibility.

The new Clinical Trials Search Portal

Health Canada’s new Clinical Trials Search Portal, which replaces the former Clinical Trials Database, allows users to search for information about clinical trials that have been authorized by Health Canada. The portal is intended to enhance transparency for patients, health care professionals, researchers, and the broader public by providing a centralized source of information about clinical trials taking place in Canada.

The portal allows users to search by various criteria: for example, by disease or condition, drug or product name, trial status, sponsor name, and date of trial approval. The portal currently includes information for approved clinical trials involving human pharmaceutical, biologic, and radiopharmaceutical drugs that meet the same criteria as Health Canada’s former Clinical Trials Database. Health Canada has indicated that future phases will include information about trials involving medical devices and natural health products, although it has not provided a timing commitment for that expansion.

Updated guidance for clinical trial applicants

Alongside the portal launch, Health Canada has provided an updated guidance document for clinical trial applicants. The updated guidance is intended to increase transparency and provide greater clarity on Health Canada’s expectations on for clinical trials.

Key points and deadlines from the guidance

• The Canadian Clinical Trial Search Portal is a search tool, not a registry. The portal displays selected information from Health Canada’s regulatory systems and international clinical trial registries. Health Canada populates it using information from the clinical trial applications that are provided to it, the World Health Organization (WHO)’s International Clinical Trials Registry Platform data, and WHO-compliant registries.
• Health Canada expects sponsors to register trials ideally before enrolment opens in Canada, and no later than 21 calendar days after the first participant is enrolled. Registration is not made through the Health Canada portals, as Health Canada does not maintain a Canadian clinical trial registry. Sponsors must register trials with an international clinical trial registry that complies with WHO standards, such as ClinicalTrials.gov or ISRCTN.
• The updated guidance is more flexible on registration timing than the 2023 draft guidance, which would have expected sponsors to register Health Canada-authorized trials before recruiting the first participant³.
• Where a multi-national trial has one or more Canadian sites, Health Canada expects sponsors to add the Canadian site or sites to the trial’s existing international record, ideally before enrolment opens at those sites, and no later than 21 calendar days after the first participant is enrolled at a Canadian site. This update is made through the sponsor’s chosen WHO-compliant registry, not through the Health Canada portal.
• Health Canada expects sponsors to submit summary results to the same registry where the trial was first registered, generally within 12 months after primary study completion. This timing expectation is consistent with the 2023 draft guidance. 
• The updated guidance adds additional details on outstanding summary results that were not included in the 2023 draft guidance. Sponsors are expected to keep registry information up to date, including by submitting any outstanding summary results information to the same WHO-compliant international registry where the trial was first registered within one year of study completion (meaning the final study visit by its last participant). In this case, sponsors are permitted to defer summary results reporting until (1) the earlier of 30 calendar days after Health Canada renders a decision or the sponsor cancels or withdraws the market authorization application, and (2) 36 months after primary study completion.
• Health Canada describes the guidance as a preparatory step before it proposes regulations for clinical trial registration and summary results reporting, but it has not identified a specific timing commitment for these regulations.

Clinical trials covered by the guidance

The guidance document applies to all sponsors who are regulated under the Act, including:

• clinical trials for phases 1 through 3 of drug development;
• clinical trials for phases 1 through 3 of natural health product development; and clinical trials (also known as investigational testing) for Classes II to IV medical devices.

The guidance document does not apply to:

• comparative bioavailability studies;
• clinical trials designed as single patient trials, also known as open label individual patient trials; 
• clinical trials for phase 4 development of drugs and natural health products used according to the terms of their marketing authorization; or
• clinical trials involving Class I devices, and licensed devices used according to the terms of their marketing authorization.

Implications for stakeholders

The launch of the Clinical Trials Search Portal and the publication of updated guidance will have practical implications for a range of stakeholders in the life sciences sector. Clinical trial sponsors, contract research organizations, and academic research institutions should consider the following:

• Confidentiality and competitive intelligence. The public availability of clinical trial information raises considerations for sponsors regarding the disclosure of proprietary data. Sponsors should review what information will be made available through the portal and appropriately manage any confidentiality concerns as they arise, particularly for early-phase trials or novel therapeutic approaches where competitive sensitivity may be heightened. 
• Compliance with updated guidance. Sponsors and their service providers should review the updated guidance documents to ensure that their current practices and standard operating procedures align with Health Canada’s revised expectations. Areas of focus should include protocol amendment procedures and documentation standards.
• Data accuracy and completeness. As clinical trial information submitted to Health Canada may now be publicly accessible, sponsors should continue to ensure, as always, that their submissions are accurate, complete, and consistent with publicly available information to avoid discrepancies that could create reputational or regulatory risk.
• International harmonization. Companies conducting multi-jurisdictional clinical trials should consider how the Canadian portal interacts with disclosure obligations in other jurisdictions, including requirements under the US Food and Drug Administration Amendments Act and the EU Clinical Trials Regulation, to ensure a consistent and coordinated approach to clinical trial transparency.

Next steps

Organizations involved in clinical trials in Canada should review Health Canada’s notice and the updated guidance documents to understand the scope of information that will be publicly available, as well as revised regulatory expectations. Sponsors should assess any necessary updates to their internal processes, confidentiality protocols, and submission practices. We will continue to monitor developments in this area and provide updates as further details become available.