Aligning federal regulations with Clinical Trials

Summary#

This is a proposed package of changes from Health Canada published in the Canada Gazette on December 20, 2025. It adjusts many existing rules so they line up with the new Clinical Trials Regulations and makes related changes to rules for drugs, devices, natural health products, cannabis, vaping and some patent provisions. The proposal is open for comment for 90 days.

What it does#

• Moves and re‑groups how clinical trials are regulated by changing or repealing parts of the Food and Drug Regulations so that many trial-related rules point to, or are replaced by, the new Clinical Trials Regulations.
• Removes or changes specific rules that previously covered clinical testing (for example, it repeals Division 5 of Part C of the Food and Drug Regulations and updates several cross-references).
• Creates carve-outs or clarifications for other rules so they work with the new approach:
  • Adds a new section to the Natural Health Products Regulations saying the Clinical Trials Regulations do not apply to the sale/import or conduct of clinical trials involving natural health products.
  • Changes the Cannabis Regulations and related cannabis research rules so that cannabis used in a clinical trial is treated as a drug in that context, and it narrows the definition of non-therapeutic cannabis research.
  • Updates the Regulations Excluding Certain Vaping Products to treat drugs used in clinical trials differently from consumer vaping products.
• Updates a special COVID-era regulation:
  • Renames the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations to focus on devices only.
  • Removes COVID‑19 drug references and keeps device trial rules, including permitting remote written informed consent when the investigator cannot get in‑person signatures.
• Makes changes that affect intellectual property and market timing:
  • Amends the Patented Medicines Regulations to recognize products used in clinical trials in certain places.
  • Changes the Certificate of Supplementary Protection Regulations definition of “authorization for sale” so that some trial-related authorizations (including some under the Clinical Trials Regulations) are excluded from counting as an authorization for sale.
• States that these amendments come into force on the same day the Clinical Trials Regulations come into force (the Gazette notice does not give that date).

Who's affected#

• Clinical trial sponsors and drug and device manufacturers who run or plan trials in Canada.
• Research hospitals, contract research organizations and clinical investigators who manage trials, including those using remote consent.
• Companies that sell or import natural health products, cannabis products, or vaping products when those products are being used in trials.
• Holders of drug patents and companies interested in certificate(s) of supplementary protection (because the changes affect what counts as an “authorization for sale”).
• Research ethics boards and institutional review bodies that approve and monitor trials.
• Regulators and legal teams who will need to update procedures and guidance to reflect the new cross-references.

If any part of the source text is unclear about how a specific rule will operate in practice, the notice does not spell out those operational details.

Why it matters#

• The package is meant to centralize and modernize how clinical trials are regulated by directing trial matters into the new Clinical Trials Regulations. That changes where to look for the rules that govern how trials are run.
• The way some products are treated for trials (natural health products, cannabis, vaping products) will change. That can affect whether a trial needs particular authorizations, licences or different regulator oversight.
• Removing some trial-related authorizations from the definition of “authorization for sale” could affect patent-related protections and market‑exclusivity calculations for drug companies. The practical effect depends on how the new rules are applied.
• Allowing remote written informed consent in device trials can make it easier to enroll participants when in-person consent is not possible.
• This is a proposal, not final law. Interested parties have 90 days from December 20, 2025 to send comments. The final legal effect depends on when the Clinical Trials Regulations are brought into force and on any further changes that come from consultation.