Proposed regulatory framework aims to better support innovative clinical trials in Canada

In December 2025, Health Canada released proposed Clinical Trials Regulations (the proposed regulations), which would establish a new regulatory framework for clinical trials involving drugs for human use. The proposed regulations would replace the existing clinical trials framework for drugs in Part C, Division 5 of the Food and Drug Regulations (FDR) and Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Health Canada aims to improve access to new and innovative therapies, and to streamline processes and regulatory efficiencies with this new framework.

What you need to know

• The proposed regulations are not law. The public consultation period for them and their associated draft guidance will close on March 20, 2026. Comments from interested parties can be submitted through the Gazette.
• The proposed regulations would replace and enhance the existing clinical trials framework for drugs, addressing various aspects of clinical trial authorization, obligations of responsible parties, adverse reaction reporting, post-trial procedures, and revocation/suspension of authorizations.
• New draft guidance for clinical trial sponsors regarding Sex- and Gender-Based Analysis Plus (SGBA Plus) Demographics Action Plans (DAPs) has been developed concurrently. While an SGBA Plus DAP will not be a regulatory requirement, sponsors are strongly encouraged to submit one to support inclusive trial design.

Proposed clinical trials regulations

Scope of the regulations, new obligations on newly defined parties, and the national REB

The proposed regulations would apply to clinical trials involving drugs for human use¹. Per an expanded definition, the “sponsor” is defined as the person who conducts the clinical trial “solely or in combination with other persons” and who takes responsibility for the overall conduct of the trial.

The definition of “investigator” has been expanded to include more types of health care professionals (for example, nurse practitioners) that may be responsible to the sponsor for the conduct of the clinical trial at a clinical trial site². Under the current regulations, the scope of a “qualified investigator” is limited to physicians and dentists. This new definition allows greater flexibility in selecting trial locations and encourages decentralized trials.

The proposed regulations define “service provider” as one who acts on behalf of the sponsor or investigator to conduct one or more trial-related activities. Although the sponsor remains ultimately responsible for conducting the trial in accordance with the law, this change means that contract research organizations (CROs) are now directly regulated under the new framework.

Research ethics boards (REBs) will continue their current mandate under the FDR of ensuring the protection of participants’ rights, safety, and well-being. However, the proposed regulations include new provisions about the composition of an REB. One of the most significant changes is the recognition of national REBs to oversee trials. The use of national REBs would streamline ethics reviews for multi-site trials by enabling a single, non–site‑specific approval of protocols and consent forms, substantially reducing duplication, lessening sponsor burden, and supporting quicker access to trials.

Clinical trial authorization

Application requirements

The proposed regulations consolidate current application requirements into a single application, which must include the full protocol, the risk-benefit information from the informed consent form, and an attestation from a senior medical or scientific officer in Canada confirming compliance of the trial under the regulations and good clinical practices. If a sponsor proposes to implement a selective approach in maintaining adverse events records relating to a drug in the trial, their application should include sufficient evidence of the drug’s safety profile to justify that approach. The protocol should include and specify the types of adverse events possible in the trial, and how the selective approach will be implemented.

Authorization process

Currently under the FDR, the sale and importation of a drug used in a trial is permitted by default within 30 days after the Minister of Health receives the application. Under the proposed regulations, the Minister will be required to issue a contingent authorization and written notice within seven days of the sponsor submitting an application. This contingent authorization does not authorize the sponsor to conduct a trial or to import/sell a drug; its only effect is that it might become a full authorization after the expiry of a 30-day period if the Minister does not object to it. For complex trials or trials dealing with vulnerable populations, the review period may be extended to 60 days via a notice to the sponsor by the Minister.

The Minister may impose specific terms and conditions on the trial authorization to mitigate risks, and/or they may require information to better manage uncertainties relating to identified risks. Examples of terms and conditions may include more frequent safety and/or efficacy reporting, adjusting inclusion and/or exclusion criteria, adapting the study population throughout the trial, or submitting final results from ongoing studies (clinical trial or post-market) in other jurisdictions.

Requirements to conduct a clinical trial at a site and post-authorization changes

As with the current regime, a clinical trial can only commence at a particular site once REB approval is secured and the investigator and REB details are submitted to the Minister. Sponsors must inform the Minister of certain changes to previously submitted information (e.g., changes to the protocol that do not alter the risk to the health of trial participants) within 15 days of those changes via a notification or an application to amend the authorization. More significant changes (including protocol changes affecting participant safety, study design, drug safety, or master‑protocol sub‑studies) require the sponsor to cease the trial and submit a formal amendment application, which would have a 30-day review period by the Minister again. Transfer of a clinical trial authorization to a new sponsor will require approval by the Minister.

Adverse drug reaction reporting

The proposed regulations supplement the requirements for adverse drug reaction (ADR) reporting by permitting the Minister to request a case report or an issue-related summary report relating to the ADR. The proposed regulations will also require a sponsor to provide information on serious ADRs that have come to the sponsor’s attention following the completion or discontinuance of a trial. This reporting requirement would apply up to 15 years, and the sponsor must report serious ADRs to the Minister within seven days of becoming aware of them.

Suspension, reinstatement, and revocation

For more risk-based oversight by the Minister, the proposed regulations enable the Minister to suspend an authorization under reasonable grounds, including:

• the conduct of the trial is likely to result in unacceptable risks to the participant’s health or the drug does not have the potential to be a therapeutic benefit for humans;
• the sponsor, investigator, or service provider has contravened the FDR or the proposed regulations; and
• the sponsor failed to comply with a term and condition on the authorization.

If the Minister intends to suspend a trial, they must first issue a written notice to the sponsor citing reasons for the suspension. The sponsor can then respond in writing. If within 30 days the sponsor provides information to the Minister confirming thresholds have been met or corrections have been made, the Minister would not be able to order the suspension.

The Minister can immediately suspend a trial if they have reasonable grounds to believe that such action is necessary to prevent injury to the health of a clinical trial participant or other person.

Note that phase IV trials (i.e., involving a commercially available drug being used within its approved indication) continue to be exempt from clinical trial authorization requirements, but must otherwise comply with the record keeping, ADR reporting and other requirements under the proposed regulations. Under the new framework, the Minister has the express authority to direct an exempted sponsor to cease a trial on a reasonable basis (similar to the reasons described above).

Good clinical practices, reporting and other activities

The proposed regulations introduce updates to good clinical practice requirements, such as emphasizing result reliability, ensuring the study population aligns with trial objectives, mandating compliance with any authorization conditions, identifying a qualified physician or dentist responsible for participant care, and allowing “documented” rather than strictly written informed consent.

Sponsors are still obligated to obtain documented informed consent for all participants in a trial. However, the proposed regulations allow for exemptions to the informed-consent requirement for trials where the objective is related to a medical emergency, although consent must be obtained afterwards as soon as feasible.

Similar to the current framework, the proposed regulations include labelling rules for trial drugs, and record maintenance requirements for protocol versions, adverse events (with certain exceptions), participant enrollment data, drug handling, REB approvals, and related documentation. The sponsor must retain clinical trial records for at least 15 years after the end of the trial.

Sex- and Gender-Based Analysis Plus Demographics Action Plans in clinical trial applications

Along with the proposed regulations, Health Canada has published new draft guidance on expectations for sponsors relating to the voluntary submission of a Sex- and Gender-Based Analysis Plus (SGBA Plus) Demographics Action Plan (DAP). This guidance is meant to support inclusive clinical trial practices, ensuring intersecting demographic factors are considered throughout a trial’s lifecycle and further supporting the federal government’s SGBA Plus Action Plan. The SGBA Plus DAP is used to assess how different factors (such as sex, age, gender, race, ethnicity, indigeneity, disability, and more) affect how Canadians experience federal health initiatives. This information helps Health Canada form responsive and inclusive health research, policies, programs, and services. 

Submitting an SGBA Plus DAP is not required, but sponsors are strongly encouraged to do so as part of their application for clinical trial authorization. When submitting an SGBA Plus DAP is not feasible, Health Canada recommends sponsors provide a clear explanation of epidemiological considerations, feasibility constraints, population homogeneity, and rare-disease challenges. The draft guidance provides strategies promoting equitable participation in the trial design to generate valid, meaningful, and generalizable clinical trial results.

What’s next?

Interested parties are encouraged to provide comments on the proposed regulations and draft guidance until March 20, 2026. After this consultation closes, Health Canada will publish an interim “What we heard” report highlighting the key takeaways and themes of the comments and take this feedback into consideration for finalizing the new framework. Here’s how to submit your feedback:

• Comments on the proposed Regulations can be submitted to through the Canada Gazette, Part I.
• Comments on the draft guidance documents can be submitted through the online stakeholder feedback form or through email to bpsip-bpspiconsultation@hc-sc.gc.ca (with the subject line: “Modernizing the framework for clinical trials – Guidance consultation comments”). Consult Health Canada for more information.