Clinical Trials Regulations update

Summary#

This is a proposed set of federal regulations from the Department of Health that would change several existing rules to tie them to the new Clinical Trials Regulations. It affects how clinical testing of drugs, medical devices, natural health products, cannabis and some vaping products are handled. The notice was published on December 20, 2025 and people can comment for 90 days after that date.

What it does#

• Updates the Food and Drug Regulations so many references to clinical testing point to the new Clinical Trials Regulations instead of older rules.
• Removes or repeals some existing parts of the drug rules (for example, a Division in Part C is removed).
• Clarifies that the Clinical Trials Regulations do not apply in some narrow situations, for example language in one place says they do not apply to the sale or importation of certain “study drugs” or the conduct of a study for those drugs (the text is technical and could be read narrowly).
• Changes the Natural Health Products Regulations so that clinical trials involving natural health products are specifically excluded from the new Clinical Trials Regulations for sale/import and conduct of the trial.
• Alters the Cannabis Regulations and related instruments so that cannabis made or sold for use in a clinical trial is treated as a drug for those purposes, and it refines what counts as “non-therapeutic” cannabis research.
• Amends the short-term COVID-19 device rules: renames the instrument to focus on devices (removes COVID-19 drugs from it), changes the definition of research ethics board, allows remote written informed consent for COVID-19 medical device trials, and removes some other temporary provisions.
• Adjusts the Patented Medicines Regulations and the Certificate of Supplementary Protection Regulations so medicines used in trials and certain trial-related authorizations are treated consistently with the new clinical-trial framework.
• Changes the rules that exclude some vaping products from the Tobacco and Vaping Products Act to add drugs used in clinical trials.
• States these amendments come into force on the same day the Clinical Trials Regulations come into force (that date is not given in this notice).

Who's affected#

• Clinical trial sponsors and contract research organizations running human trials.
• Drug manufacturers and importers who supply investigational or “study” drugs.
• Medical device makers and researchers doing COVID-19 device trials.
• Companies and researchers working with cannabis in clinical trials.
• Natural health product firms if their products are used in human clinical trials.
• Holders of drug patents and those using the Patented Medicines Regulations or Certificate of Supplementary Protection Regulations.
• Manufacturers or importers of vaping products that might be treated as drugs for trial purposes.
• Research ethics boards that review human trials.
  If anything above is unclear in how it will operate in practice, the regulatory text itself is technical and could require interpretation by regulators or legal advisers.

Why it matters#

• The changes move many clinical-trial rules into a single new set of rules (Clinical Trials Regulations). That aims to make the rules clearer for sponsors and researchers.
• Reclassifying cannabis, natural health products, some vaping products and certain drugs for trial purposes may change licensing, reporting, and who needs approvals.
• Allowing remote written consent for some COVID-19 device trials is a practical change that can make it easier to enroll people when in-person contact is difficult.
• Some technical changes affect patent and supplementary protection processes for medicines used in trials, which could matter to drug developers and their legal teams.
• The amendments are proposed, not final. Interested parties have 90 days from December 20, 2025 to comment. The rules only take effect when the Clinical Trials Regulations themselves come into force — that date is not specified here.