On December 20, 2025, Health Canada announced draft Clinical Trial Regulations (CT Regulations) and related guidance that would revamp how clinical trials are regulated in Canada. The draft regulations are intended to clarify and simplify existing rules and establish a modernized framework of flexible, risk-based oversight to better support innovative trials, reduce regulatory burden, and enhance participant access and safety.

According to Health Canada, this more flexible and internationally aligned framework would also attract global investment, increase research capacity, and expand access to new therapies. Health Canada is accepting feedback on the draft CT Regulations and related guidance documents until March 20, 2026.

Background

  • A clinical trial is a research study involving human participants that is used to evaluate the safety, effectiveness, and/or quality of new drugs, devices, and other medical interventions and products.
  • Clinical trials of drugs in Canada are currently regulated under (i) Part C, Division 5 of the Food and Drug Regulations; and (ii) Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Both sets of regulations would be replaced by the CT Regulations, when brought into force.
  • The draft CT Regulations are part of Health Canada’s Clinical Trials Regulatory Modernization initiative. Many regulatory flexibilities for clinical trials were piloted during the COVID-19 pandemic. In 2021, Health Canada consulted on modernizing the regulatory framework for clinical trials and in 2022 published a What We Heard report. Stakeholder comments were taken into consideration in developing the CT Regulations.

Application

The CT Regulations would apply to clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. They would not apply to natural health products and non-therapeutic research on cannabis. Health Canada intends to update the regulation of clinical trials for other product types, such as medical devices and natural health products, at a later date. 

New regulatory features

The CT Regulations keep in place much of the current regulatory framework, while adding new regulatory features, including:

  • Shift to regulating conduct of clinical trial: The current regulations oversee the conduct of clinical trials indirectly by regulating the importation and sale of drugs used in such trials. Under the draft CT Regulations, Health Canada would retain these powers while gaining direct oversight over the conduct of clinical trials throughout their lifecycle. The oversight would be flexible and risk based and would be an essential component of Health Canada’s commitment to enhancing patient safety.
  • Review process; extended timelines: Under the draft CT Regulations, on submission of a clinical trial application, Health Canada will issue an acknowledgement letter and a “contingent authorization” within 7 days. A contingent authorization would not authorize importation of a drug or other regulated activity while the application is under review. The contingent authorization would become a full authorization after (i) the 30-day review period elapses without any notice of objection from Health Canada; or (ii) Health Canada issues a “notice of no objection”. Health Canada can extend the review period by 30 days in certain cases, including to evaluate complex clinical trials or a vulnerable study population. These rules represent some of the measures implemented to transition towards regulating clinical trials.
  • Agile oversight: The draft CT Regulations provide for increased flexibility and innovative trial designs. These include master protocol trials, which may involve multiple sub-studies testing different drugs for the same condition or a single drug for different conditions, and decentralized trials, which allow trial activities to be conducted outside of traditional clinical trial centres, bringing research closer to participants.
  • Terms and Conditions: Under the draft CT Regulations, Health Canada could impose terms and conditions on a clinical trial authorization at any point to mitigate risks or address uncertainties. Terms and conditions may allow Health Canada to authorize trials that might otherwise be rejected. Examples of terms and conditions include more frequent safety and/or efficacy reporting and monitoring specific study populations. Imposing terms and conditions constitutes an essential aspect of Health Canada’s risk-based approach aiming to ensure that requirements are implemented with appropriate flexibility and adaptability, taking into account the particular risks associated with each trial.  
  • National Research Ethics Board: The draft CT Regulations would allow for the use of a national research ethics board that can approve the clinical trial protocol and informed consent form across multiple trial sites in Canada. This would reduce duplicative reviews at each trial site. Again, this falls within Health Canada’s objective to introduce flexibility while strengthening compliance promoting activities.
  • Post-Trial Reporting: The draft CT Regulations would allow Health Canada to impose new post-trial obligations, including reporting serious unexpected adverse drug reactions for up to 15 years post-trial (for drugs not approved in Canada for any indication), thereby enhancing patient safety.

Coming Into Force

Once finalized, the CT Regulations would come into force 12 months after they are published in the Canada Gazette, Part II.

Related Draft Guidance

Draft guidance has been published alongside the draft CT Regulations:

  • Draft guidance on clinical trial applications: Describes the requirements and procedures for clinical trial applications under the draft CT Regulations.
  • Draft guidance on proposed new Clinical Trials Regulations: Provides Health Canada’s interpretation of the provisions in the draft CT Regulations.
  • Draft guidance document on sex and gender-based analysis: Submission of a demographics action plan is not a regulatory requirement but is encouraged by Health Canada. This guidance promotes inclusive practices in clinical trials to reflect population diversity and support equitable drug development.

Aligning other Regulations

Health Canada has also proposed Regulations Amending Certain Regulations Relating to Clinical Trials that would repeal the current provisions regulating clinical trials and align other regulations with the proposed CT Regulations.

Consultation on CT Regulations and related guidance

Health Canada is currently seeking feedback on the proposed CT Regulations. The consultation will close on March 20, 2026.

Parallel consultation on decentralized clinical trials guidance

Health Canada is also consulting until February 21, 2026 on new draft guidance on decentralized clinical trials. As discussed above, in decentralized clinical trials, some or all trial-related activities are conducted remotely with the help of digital health technologies and virtual methods. This can reduce the travel burden for participants and make trials more accessible and diverse. The draft guidance is an interim measure to support decentralized clinical trials under current regulations (i.e., Part C, Division 5 of the Food and Drug Regulations) and will be updated once the CT Regulations are brought into force.

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