New Clinical Trials Regulations

Summary#

On December 20, 2025, Health Canada published a proposed new set of rules called the Clinical Trials Regulations under the Food and Drugs Act.
If adopted, these rules would move Canada from mainly regulating the sale/import of trial drugs to directly regulating how drug clinical trials are run, with new tools for risk-based oversight and more flexibility for decentralized trials.

What it does#

• Creates a new, stand-alone Clinical Trials Regulations that would replace the current drug trial rules in Part C, Division 5 of the Food and Drug Regulations and parts of the COVID-19 CT Regulations.
• Changes who needs permission: sponsors would generally need an authorization to run a trial, but trials that use only already‑authorized drugs exactly as approved may be exempt.
• Shifts oversight to trial conduct (not just drug import/sale). That lets Health Canada impose targeted requirements, called terms and conditions, at any time during a trial.
• Lets the regulator:
  • issue a contingent notice within 7 days of a complete application, with a default authorization after 30 days (extendable to 60 days for complex trials);
  • impose or change terms and conditions to manage risks or collect more data;
  • suspend or revoke only part of a trial (for example one arm or sub‑study) and to suspend multiple authorizations if the same party causes problems.
• Introduces more flexibility to support decentralized trials:
  • allows “documented informed consent” (including electronic or recorded oral consent) instead of strictly written signatures;
  • broadens who can be an investigator (for example beyond only physicians and dentists);
  • clarifies that a clinical trial site can include a main location plus remote locations.
• Brings service providers (for example contract research organizations) under direct regulatory obligations for records, reporting and good clinical practices.
• Lets sponsors propose a selective approach to recording non‑serious adverse events for drugs with well‑characterized safety profiles.
• Sets record retention at a minimum of 15 years for trial records.
• Transition and timing:
  • the draft says the rules would come into force 12 months after they are published in the Canada Gazette, Part II.
  • public comments are invited for 90 days after the Part I publication notice.
• Estimated financial effects (as presented by Health Canada):
  • industry savings from reduced relabelling and record rules: $23.3 million (present value, PV, over 10 years);
  • new industry costs for additional reporting and conditions: $7.3 million (PV, 10 years);
  • expected Health Canada costs to run the new system: $15.7 million (PV, 10 years);
  • estimated net monetized benefit: $313,926 (PV over 10 years);
  • a scenario estimating 5 additional trials per year could attract about $3.3 billion (PV) of new clinical trial investment over 10 years.

Who's affected#

• Sponsors of drug trials: pharmaceutical companies, biotech firms, academic groups and hospitals. They will face new application, reporting and possible terms‑and‑conditions requirements.
• Investigators and clinical teams: physicians, dentists and a broader range of regulated health professionals (for example nurse practitioners) who may now act as investigators in some trials.
• Service providers: contract research organizations, labs and other groups that run trial activities. They would have direct record and compliance obligations.
• Research ethics boards (REBs): the rules formally allow a national REB option and change some membership rules.
• Trial participants and patient groups: people who take part in trials — especially those in rural or remote areas and people with rare diseases — because the rules aim to make decentralized trials easier.
• Health Canada and government reviewers: they would take on more active oversight and administrative work.

If it is unclear who will be affected by a specific provision in practice, the Department’s guidance and follow‑up consultations are meant to clarify details.

Why it matters#

• Makes it easier to run innovative or complex trials in Canada. That can speed up recruitment and help bring more trials here — potentially giving patients earlier access to experimental treatments.
• Supports decentralized trials (remote visits, electronic consent), which can widen participation for people who live far from major centres.
• Gives regulators more precise tools (terms and partial suspensions) to manage safety problems without stopping an entire trial. That can keep safe parts of a study running.
• Adds new responsibilities and costs for sponsors and service providers (more reporting, possible conditions). Big and small organizations should assess readiness.
• Aims for international alignment and to attract investment; Health Canada estimates modest net monetary gains and a larger potential boost in clinical R&D spending.
• This is a proposal, not law. The draft is open for public comment for 90 days from the notice, and the rules would only take effect after final publication and the stated 12‑month delay.