Canada's Clinical Trials Portal: What Sponsors Must Now Register and Disclose

For years, registering a Canadian clinical trial and disclosing its results was informal practice. Many sponsors did it because good science and international norms called for it, not because a Canadian document told them to. That has changed. On 29 July 2026 Health Canada launched a public clinical trials search portal and, alongside it, finalised a guidance document that sets out clear policy expectations for sponsors on registration and results disclosure. Transparency in Canadian clinical trials has moved from convention to stated expectation.

The change matters for anyone running a Health Canada authorised trial, whether the product is a drug, a natural health product or a medical device. It is a policy-first move. Health Canada is telling sponsors what it expects before it decides whether to write those expectations into regulation. Sponsors that build a documented registration and disclosure procedure now will be ready if and when the rules harden. This guide explains what launched, which trials are in scope, and what a sponsor should do about it.

Executive summary

Health Canada launched Canada's search portal for clinical trials on 29 July 2026, replacing the 2013 Clinical Trials Database. The portal is a public search tool, not a registry. It initially publishes information on drug trials, meaning human pharmaceutical, biologic and radiopharmaceutical drug trials, for phases 1 to 3 approved since 1 April 2013, and links out to international registries for the full record. Separately, Health Canada finalised its guidance on the registration of clinical trials and public disclosure of results. The guidance applies to all sponsors of trials regulated under the Food and Drugs Act, including phase 1 to 3 drug and natural health product trials and Class II to IV medical device investigational testing. It asks sponsors to register authorised trials prospectively with a registry that meets World Health Organization standards, and to report summary results.

What Health Canada launched

What it is. Two things launched together on 29 July 2026: a public search portal and a final guidance document. The clinical trials search portal gives patients, researchers and the public a bilingual, searchable view of Canadian clinical trials, with weblinks to the international registry that holds the full record. The guidance on registration and public disclosure of results sets out what Health Canada expects sponsors to do so that the information feeding the portal is complete and reliable.

Why it matters. The portal is public and it is searchable, so a sponsor's registration behaviour is now visible. If a trial is not registered in a WHO-standard registry, or the registry record is thin or out of date, that shows. Health Canada has also said the portal replaces the database it launched in 2013, so the informal era is closing. The reputational and access-to-participants stakes of good registration are higher than they were.

What companies should do. Treat registration and results disclosure as a defined process with an owner, not an ad hoc task. Confirm that each authorised trial is registered in a compliant registry, ideally before enrolment opens in Canada and no later than 21 calendar days after the first participant is enrolled, that the protocol code in the registry matches the one in your Health Canada application, and that summary results are reported within 12 months of primary study completion.

The portal is a search tool, not a registry

This distinction is easy to miss and important to get right. A registry holds the comprehensive record of a trial, provided and maintained by the sponsor. The Health Canada portal holds only select information and points users to the registry for the rest. To populate the portal, Health Canada uses automated technology to pull information from three sources: its own regulatory data management systems, international registries that follow WHO standards, and the WHO International Clinical Trials Registry Platform, known as the ICTRP.

From Health Canada's systems, the portal shows details such as the protocol title, sponsor name, medical condition, sponsor's protocol code, Health Canada control number and the date of the no objection letter. From registries or the ICTRP, it shows trial status, phase, locations, contact details, completion date, a short title, the registry weblink and the weblink to summary results. The portal is updated regularly as trials are approved and as registry information changes.

What the portal includes and excludes

The final guidance: policy expectations for sponsors

What it is. The guidance document is final, not draft. Health Canada consulted stakeholders on a draft between 23 February and 24 April 2023, and the comments informed the final guidance and portal. The final guidance sets out the policy expectations for sponsors of Canadian clinical trials regulated under the Food and Drugs Act: register and report summary results using registries that comply with WHO standards, which ensure that registry owners collect and validate data in a consistent, high-quality way.

Why it matters. The guidance scope is broader than the portal. While the portal initially publishes drug trials only, the guidance applies to sponsors across drugs, natural health products and medical devices. If you sponsor a Class II to IV device investigational test or an NHP trial, the registration and disclosure expectations apply to you even though your trial may not yet appear in the public portal.

What the guidance covers

What sponsors should now do

The guidance points to a small number of concrete behaviours. First, register the authorised trial ideally before it has opened for enrolment in Canada, and in any case no later than 21 calendar days after the date of enrolment of the first participant, in line with WHO standards. Second, use a registry that complies with WHO clinical trial registry standards, including data providers accepted by the WHO ICTRP. These registries provide public access and comprehensive information. Third, include the protocol number in the registry record and provide a clear listing of Canadian trial site locations. Fourth, submit summary results to the same registry within 12 months following primary study completion, and keep the registry record up to date.

These are process expectations, and process is where sponsors either succeed or fail an inspection. A defensible approach assigns a named owner for registry maintenance, sets a trigger that ties registration to a point before first-participant recruitment, and builds a standard operating procedure that covers registration, ongoing updates and results reporting. Aligning this with your wider quality system, including your SOP framework, keeps it durable rather than person-dependent.

The AI matching caveat and why protocol codes matter

Health Canada uses artificial intelligence to help populate the portal, mainly to match its approved trials to international registry records and to translate short titles from English to French. At launch, about 17 percent of trials were matched using AI rather than by a direct protocol code match. Health Canada is candid that AI matching can introduce errors, including links to the wrong registry record and differences between the short title and the official protocol title. It notes that the official protocol title will always represent the trial that Health Canada approved.

There is a practical takeaway for sponsors here. You can reduce the risk of a mismatched or incorrect portal record by making sure the protocol code in the registry's secondary identifiers or other study ID number fields is identical to the code in your Health Canada application. If you spot a matching error, Health Canada asks sponsors to email the portal team with the protocol title, protocol code, Health Canada control number and the correct registry identifier such as the NCT number. Clean, consistent identifiers are the cheapest form of quality control you can do here.

Why this matters now, and how it connects to E6(R3)

Health Canada has framed this as a policy-first approach. The stated logic is that a policy expectation lets sponsors develop or update their registration and disclosure practices before Health Canada would step in and propose any regulatory requirements. In plain terms, this is a signal. Sponsors that treat transparency as optional are betting that the policy will never become a rule. That is a weak bet, and the cost of getting ahead of it is low.

It also lands in the same window as a bigger shift in trial conduct. ICH E6(R3) good clinical practice is being implemented in Canada with an October 2026 milestone, bringing a quality-by-design and risk-proportionality mindset to trial oversight. Registration and disclosure discipline fits naturally inside an E6(R3) quality management approach, and the decentralized trial expectations in Annex 2 raise the premium on accurate, well-maintained trial records. A sponsor building E6(R3) readiness should fold the portal and disclosure guidance into the same programme rather than treating them as separate tasks.

Registration and disclosure compliance checklist

• Confirm scope. Determine whether each trial is in scope: phase 1 to 3 drug or NHP development, or Class II to IV device investigational testing, regulated under the Food and Drugs Act.
• Register on time. Register the authorised trial in a WHO-standard registry, ideally before enrolment opens in Canada and no later than 21 calendar days after the first participant is enrolled.
• Choose a compliant registry. Use a registry that meets WHO clinical trial registry standards, including data providers accepted by the WHO ICTRP.
• Align the protocol code. Make the registry protocol code identical to the code in your Health Canada application to avoid AI-assisted mismatches.
• List Canadian sites. Include a clear listing of Canadian trial site locations in the registry record.
• Keep the record current. Assign a named owner to maintain and update the registry record throughout the trial.
• Disclose summary results. Submit summary results to the same registry within 12 months following primary study completion, and keep the record current.
• Write the SOP. Capture registration, ongoing updates and results reporting in a documented procedure tied to your quality system.

Common mistakes

Assuming the guidance is still a draft. It is final. The consultation ran in 2023, and the final guidance was published with the portal on 29 July 2026.

Confusing the portal with a registry. The portal is a search tool that links out. Your obligation is to register and maintain the full record in a WHO-standard registry.

Registering late. The expectation is registration ideally before enrolment opens, and no later than 21 calendar days after the first participant is enrolled, not weeks into the trial.

Ignoring device and NHP trials. The portal shows drug trials first, but the guidance covers Class II to IV device investigational testing and phase 1 to 3 NHP trials too.

Mismatched protocol codes. If the registry code does not match the Health Canada application, your trial may be matched by AI and linked to the wrong record.

Frequently asked questions

When did Health Canada launch the clinical trials search portal?

Health Canada launched Canada's search portal for clinical trials on 29 July 2026. It replaces the 2013 Clinical Trials Database and carries information on trials approved since 1 April 2013.

Is registering a clinical trial in Canada now mandatory?

The guidance sets out a policy expectation, not a new regulatory requirement. Health Canada describes it as a policy-first approach that lets sponsors update their practices before it considers proposing regulatory requirements. The practical advice is to register and disclose as if it were required, because a documented procedure protects you either way.

Which trials does the guidance apply to?

It applies to all sponsors of trials regulated under the Food and Drugs Act: phase 1 to 3 drug development, phase 1 to 3 natural health product development, and investigational testing for Class II to IV medical devices. It does not apply to comparative bioavailability studies, single patient trials, phase 4 drug and NHP trials used within the marketing authorization, or Class I and licensed devices used within their marketing authorization.

What registry should a sponsor use?

Use a registry that complies with the WHO clinical trial registry standards, including data providers accepted by the WHO International Clinical Trials Registry Platform, the ICTRP. These registries provide public access and comprehensive information, and Health Canada draws on them to populate its portal.

Does the portal show medical device and natural health product trials?

At launch, the portal publishes drug trials only, meaning pharmaceutical, biologic and radiopharmaceutical drug trials. The guidance expectations, however, extend to natural health product and Class II to IV medical device trials, so sponsors of those trials should register and disclose even if their trial is not yet visible in the public portal.

How can a sponsor avoid an incorrect portal listing?

Make sure the protocol code in the registry's secondary identifier fields is identical to the code in your Health Canada application, so the trial is matched by code rather than by AI. If you find an error, email the Health Canada portal team with the protocol title, protocol code, Health Canada control number and the correct registry identifier.

How MFLRC can help

MF License and Regulatory Consultants helps sponsors turn Health Canada's registration and disclosure expectations into a working process. That includes drafting a clinical trial registration and disclosure SOP, assigning registry-maintenance ownership, aligning protocol codes across your application and registry records, and building the whole thing into an ICH E6(R3) readiness plan so registration, disclosure and quality management move together. We also connect this work to inspection readiness and to the data integrity and audit trail expectations that inspectors increasingly focus on.

Whether you need a standalone registration and disclosure procedure or a broader regulatory affairs and licensing and quality systems review, we tailor the work to your product type and trial portfolio.

Need help turning the new clinical trials guidance into a documented, inspection-ready process? Book a consultation for a scoped review of your registration and disclosure readiness.

Conclusion

The launch of Canada's clinical trials portal and the final registration and disclosure guidance closes the informal era of Canadian trial transparency. The portal makes registration behaviour visible, and the guidance tells sponsors plainly what Health Canada expects. None of it is heavy on paperwork, but all of it is easy to get wrong if it is left to memory rather than procedure. Sponsors that register prospectively, keep registry records accurate and aligned, and disclose results will be ready if the policy becomes a rule. Those that wait are making a bet that transparency stays optional. It will not.

Sources and references

• Canada's search portal for clinical trials: About the portal (Health Canada)
• New guidance and public search portal for clinical trials approved in Canada: Notice, 29 July 2026 (Health Canada)
• Guidance on the registration of clinical trials and public disclosure of results (Health Canada)
• WHO International Standards for Clinical Trial Registries (World Health Organization)
• Clinical trials modernization (Health Canada)