Amendments to Clinical Trials Regulations

Summary#

This is a proposed set of changes titled Regulations Amending Certain Regulations Relating to Clinical Trials published on December 20, 2025 by Department of Health. It moves and clarifies how clinical-trial activities are regulated across several rules (drugs, devices, natural health products, cannabis, patents and vaping), and is open for public comment for 90 days after publication.

What it does#

• Creates a clearer split between general rules and the new Clinical Trials Regulations, removing or moving overlapping rules in the Food and Drug Regulations (Part C) and related instruments.
• Excludes certain activities from the Clinical Trials Regulations in specific places, for example saying the Clinical Trials Regulations do not apply to the sale or importation of some study drugs or to the conduct of some studies (as those are handled elsewhere).
• Repeals or replaces parts of existing rules that overlap with the Clinical Trials Regulations, including parts of Division 5 of Part C of the Food and Drug Regulations and sections of the Natural Health Products Regulations.
• Changes how cannabis and cannabis research are treated:
  • Updates the Cannabis Regulations and related amendments so cannabis sold for clinical trials can be treated as a drug for those trials.
  • Clarifies what counts as “non-therapeutic research on cannabis” versus a clinical trial.
• Narrows the earlier COVID-19 device/drug rules:
  • Renames the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations to focus on devices only.
  • Removes COVID-19 drug provisions and keeps a rule allowing remote written informed consent for certain COVID-19 medical device trials.
• Adjusts intellectual property/market exclusivity rules:
  • Amends the Patented Medicines Regulations and the Certificate of Supplementary Protection Regulations to account for drugs used in clinical trials and to clarify what counts as an authorization for sale.
• Removes some vaping products from the scope of the Tobacco and Vaping Products Act when they are regulated as drugs or are used in clinical trials under the Food and Drug Regulations.
• States that these amendments will come into force on the day the Clinical Trials Regulations come into force.

Who's affected#

• Drug and medical device companies that run or sponsor clinical trials.
• Sponsors and researchers who design or conduct trials, including those working with natural health products or cannabis.
• Regulatory affairs, legal and patent teams concerned with market authorizations and supplementary protection.
• Ethics committees and research institutions that review clinical trials.
• It may indirectly affect patients or trial participants if trial setup or access to investigational products changes.

If anything is unclear about who is covered by a specific change, the published text ties many effects to how the final Clinical Trials Regulations are written.

Why it matters#

• It aims to reduce overlap and confusion by shifting many clinical-trial rules into a single set of Clinical Trials Regulations, which could make it clearer where sponsors must apply for permissions.
• Changes to how cannabis, natural health products, vaping products and COVID-19 device trials are treated could affect how those trials are authorized and run.
• Updates to patent and supplementary protection rules could change how time-limited market protections are calculated for drugs tested in trials.
• Allowing remote written consent for certain COVID-19 device trials can make it easier to enroll participants when in-person consent is difficult.
• These are proposed changes. Stakeholders can comment during the 90-day consultation period starting December 20, 2025.