Health Canada Proposes Risk-Based Clinical Trials Framework to Streamline Drug Development
Health Canada released proposed Clinical Trials Regulations in December 2025 that would establish a new regulatory framework for drug trials, replacing existing rules with a streamlined, risk-based approach aimed at improving access to innovative therapies.
In December 2025, Health Canada released proposed Clinical Trials Regulations that 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 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.
The proposed regulations would apply to clinical trials involving drugs for human use. 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 site. 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 are now directly regulated under the new framework.
Research ethics boards will continue their current mandate under the Food and Drug Regulations of ensuring the protection of participants' rights, safety, and well-being. However, the proposed regulations include new provisions about the composition of a research ethics board. One of the most significant changes is the recognition of national research ethics boards to oversee trials. The use of national research ethics boards 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.
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.
Currently under the Food and Drug Regulations, 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.
As with the current regime, a clinical trial can only commence at a particular site once research ethics board approval is secured and the investigator and research ethics board details are submitted to the Minister. Sponsors must inform the Minister of certain changes to previously submitted information, such as 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.