Clinical Trials Regulations for Drugs

Summary#

This is Health Canada’s Regulatory Impact Analysis Statement for the proposed Clinical Trials Regulations under the Food and Drugs Act.
If adopted, the rules would create a new federal framework to authorize and oversee the conduct of drug clinical trials in Canada, modernize reporting and inspection powers, and add flexibilities for remote (“decentralized”) trials.
Health Canada estimates a small net monetary benefit ($313,926 PV over 10 years) and forecasts about $3.3 billion PV in new R&D investment if a few more trials locate to Canada. The notice was published on December 20, 2025 and the public may comment for 90 days; the regulations would come into force 12 months after they are published in the Canada Gazette, Part II.

What it does#

• Replaces the current drug-trial rules in Part C, Division 5 of the Food and Drug Regulations and parts of the COVID-19 CT Regulations with a stand‑alone Clinical Trials Regulations.
• Makes sponsors responsible for holding an authorization to conduct most drug trials. Some low‑risk trials using already‑authorized drugs may be exempt from prior authorization if they use the drug “as authorized.”
• Introduces a two-step authorizing process: a contingent authorization (issued quickly) that becomes an authorization by default after 30 days (extendable to 60 days for complex files).
• Gives the Minister new powers to impose and change terms and conditions on an authorization at any time to manage risks.
• Expands who can act as an investigator (beyond physicians/dentists) to permit other regulated health professionals. This supports decentralized trial models.
• Replaces “written informed consent” with flexible “documented informed consent” to allow electronic signatures or documented oral consent in appropriate situations. It also includes a defined emergency exception where prior consent is impossible.
• Enables voluntary use of a national research ethics board (a “national REB”) to review multi‑site trials so a single ethics approval can cover many sites.
• Adds direct regulatory oversight of service providers (for example, contract research organizations) and requires sponsors to disclose service‑provider contacts.
• Sets reporting rules: faster reporting for fatal or life‑threatening serious unexpected adverse drug reactions; Health Canada may request case reports or issue‑related summary reports; allows certain post‑trial reporting where long‑term risks are suspected.
• Keeps a record retention requirement of at least 15 years for trial records, with some limited exemptions for authorized drugs used as authorized.
• Allows partial suspensions or revocations of authorizations (for example, one arm of a multi‑arm trial), and allows directions to stop trials that are exempt from prior authorization.
• Includes transition rules for applications and trials already underway.
• Health Canada plans guidance documents and an implementation lead time. The federal cost/benefit estimates include industry savings from reduced labelling and record burdens ($23.3 million PV), and new compliance costs to industry ($7.3 million PV) and to Health Canada ($15.7 million PV).

Who's affected#

• Sponsors of clinical trials: pharmaceutical and biotechnology companies, academic sponsors and other organizations applying to run drug trials in Canada. (Referred to as “sponsors” in the proposal.)
• Service providers and contract research organizations that run trial activities on behalf of sponsors.
• Investigators and clinical teams, including a broader range of regulated health professionals (for example, nurse practitioners) who could now qualify to lead site activity.
• Research ethics boards (REBs) and potential national REBs that will approve protocols and consent documents.
• Trial participants and patient groups, especially people in remote areas or with rare conditions who might benefit from decentralized trial options.
• Health Canada, which would gain new oversight and review responsibilities.
• Provincial regulators and health-care licensing bodies, because the proposal depends on provincially regulated practitioners and on laws about consent and privacy.
• Small businesses and sponsors: Health Canada estimates a small number (about four) of impacted small businesses explicitly in its analysis.
  If some details are unclear in the proposal (for example, exactly how national REBs will be listed or how remote‑data standards will be enforced), Health Canada says it will provide guidance.

Why it matters#

• It changes how Canada regulates drug clinical trials. Instead of mostly regulating drug import/sale for trials, the government would regulate the actual conduct of trials. That gives Health Canada more direct and flexible oversight tools, like imposing targeted terms and conditions and suspending parts of trials rather than whole trials.
• It makes it easier to run newer trial designs and decentralized trials in Canada. The rules on documented consent, broader investigator roles, and national REB use aim to reduce barriers for remote participation and multi‑site studies. That could improve access for rural patients and people with rare diseases.
• It could alter costs and paperwork. Health Canada estimates industry net savings from some regulatory changes (notably fewer labelling and certain record requirements) — the analysis counts $23.3 million PV in industry savings against $7.3 million PV in new industry costs, and $15.7 million PV in departmental costs; the overall modeled net benefit is $313,926 PV over 10 years. These are Health Canada’s estimates and involve assumptions about trial numbers and behaviour.
• It gives Health Canada more power to oversee service providers directly. That should help enforcement in cases of non‑compliance, but sponsors and service providers may face new obligations.
• The proposal is not law yet. This notice invites public comments for 90 days. If finalized as published, the rules would take effect 12 months after they appear in the Canada Gazette, Part II.