To run a drug trial in Canada a sponsor files a clinical trial application with Health Canada and also needs research ethics board approval at each site. This guide explains the pieces, the 30-day default review, and the new rules now proposed. Not legal advice.
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Prepare the CTA
Form, protocol, Investigator Brochure, quality data, consent
File with Health Canada
Complete application starts the review clock
Default review period
30 days under Division 5, unless objected
No Objection Letter
Authorises the trial to proceed
REB approval at each site
Needed before the site enrols
Conduct, amend, report
Amendments and safety reports follow the rules
The Canadian CTA in one page
The framework
In Canada, trials of drugs in humans are regulated federally by Health Canada under the Food and Drugs Act and, for the application process, Division 5 of Part C of the Food and Drug Regulations. A sponsor who wants to sell or import a drug for the purpose of a clinical trial files a clinical trial application. Health Canada reviews it for safety and quality and, in general, the trial is considered authorised if no notice of objection is sent within the default review period.
Good clinical practice is expected throughout. The ICH framework underpins it, and our guides to good clinical practice and the ICH E6(R3) update cover the principles. Provinces and institutions add their own ethics and contracting rules on top, which is one reason Canadian start-up is often described as parallel work streams.
If you have read our guides to the FDA IND application or the EU Clinical Trials Regulation, the structure will feel familiar. The notable differences are the short default review clock and that REB approval is obtained separately from the authority filing.
The dossier
Based on Health Canada guidance as summarised in public sources. The current guidance for clinical trial sponsors is the reference for exact forms and wording.
| Component | What it is | Link to your data system |
|---|---|---|
| Application form | The Health Canada application form (HC/SC 3011) with sponsor and trial details and attestations. | Consistency of trial identifiers and phase across documents. |
| Protocol and synopsis | Objectives, design, methodology, statistical considerations and organisation of the trial. | The visits, windows and assessments your forms must reproduce. |
| Investigator Brochure | The current clinical and nonclinical summary of the product. | Safety reporting thresholds and expected events. |
| Quality information | Chemistry and manufacturing data, usually in the Common Technical Document modules. | Drug accountability and dispensing records if you track them. |
| Consent materials | Informed consent documents submitted with the application. | The consent text your electronic or paper process must use. |
| Site information | Information about each clinical trial site and qualified investigator. | Site set-up, roles and training records. |
Check the current Health Canada guidance for the full list, including attestations required from the qualified investigator and the sponsor.
Upload your protocol to draft the visit schedule and forms, review every item, and test edit checks and the audit trail in the free sandbox.
How to proceed
Everything else in the dossier references them. Agree the version you are filing and keep a clear change history.
Use the Health Canada guidance for the form, modules and attestations. Make sure identifiers and phase match across documents.
The review clock starts from a complete application, so an incomplete filing costs time. Respond to any questions from Health Canada promptly.
Each site needs REB approval. Prepare consent materials and site documents early. Our eConsent regulations guide helps if you use electronic consent.
While reviews run, draft the visits and forms from the approved protocol and test them. See study start-up for investigator-initiated trials.
Do not enrol before authorisation and site REB approval. Changes later go through the amendment route in the regulations. Our guide to protocol amendments shows how to keep forms in step.
What is changing
Health Canada has been modernising its clinical trial framework for several years. Draft Clinical Trial Regulations were pre-published in Canada Gazette, Part I on 20 December 2025, with a comment period that closed in March 2026. The draft is described as replacing Division 5 for drug trials. As of our check, the regulations are not final.
Sources disagree on timing. Health Canada's consultation summary expects the final text in Canada Gazette, Part II in spring 2027 followed by a one-year coming-into-force period, while an earlier forward regulatory plan listed summer 2026. We therefore cannot give you a date. Draft proposals reported publicly include an acknowledgement and a contingent authorisation followed by a full authorisation, but these are draft details that may change.
What to do about it: plan to the rules in force today, build your systems so they can adapt, and set a reminder to read the final regulations and guidance when they publish. Controlled, well-documented systems cope with rule changes better than ad hoc ones.
Capture is the data side of the trial. It does not file a CTA for you and we make no claim of Health Canada approval. It provides Part 11-aligned controls including a field-level audit trail, e-signatures, role-based access, a draft to approved form lifecycle and a blank eCRF PDF export that can support your ethics submissions. Data can be hosted in the EU or in the USA. Ask your regulatory adviser about cross-border data questions for Canadian participants.
CTA
In review
REB sites
1 of 3 approved
Checklist
Protocol, synopsis, consent and eCRF all reference one version number.
Check every data type in the forms appears in the consent text.
Qualified investigators and staff are identified and their roles configured.
Know who receives serious adverse event reports and how fast, and test the form.
Define who requests, approves and releases changes to forms.
Know where records live and how they will be retained. See data archiving and retention.
A CTA is the dossier a sponsor files with Health Canada to sell or import a drug for a clinical trial in Canada. It includes the application form, protocol, Investigator Brochure, quality information, consent materials and site information.
Division 5 sets a 30-day default review period from a complete application. A 2020 ministerial order extended it to 45 days at that time, so check Health Canada for the period that applies now.
It is the letter Health Canada commonly issues to confirm it has no objection to the trial proceeding. The trial can also be treated as authorised if no notice of objection is sent within the default period. Check the current guidance for details.
Yes. A research ethics board must approve the trial at each site before enrolment. This is separate from the Health Canada authorisation.
Draft Clinical Trial Regulations were pre-published in Canada Gazette, Part I on 20 December 2025. They are not final as far as we could verify, and sources differ on when the final text will publish.
Both are authority-level filings, but Canada uses a CTA reviewed on a short default clock and obtains REB approval separately. See our FDA IND guide and Part 312 explainer for the US route.
Capture is a general-purpose EDC with Part 11-aligned controls. We do not claim Health Canada approval or certification. Check data residency and privacy requirements with your advisers.
No. It is orientation. Use the current Food and Drug Regulations and Health Canada guidance, and consult a regulatory professional.
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