- in Canada
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. This initiative is one of Health Canada's red tape reduction initiatives to streamline processes and enhance regulatory efficiency, and follows Health Canada's 2021 clinical trials modernization consultations. The proposed new stand-alone Clinical Trials Regulations would replace the clinical trial provisions in Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects) and Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
The proposed framework aims to improve access to new and innovative therapies for people in Canada by better supporting innovative trials throughout a trial's life cycle, while maintaining strong safety protections for participants.
The proposed Clinical Trials Regulations would apply to both authorized drugs and drugs that are not currently authorized in Canada. They would directly regulate the conduct of clinical trials, establishing requirements for the application process, issuance, terms and conditions, amendment, suspension, and revocation of clinical trial authorizations. They also set out requirements for good clinical practices, reporting, and other activities related to clinical trials.
Health Canada has also released three associated draft guidance documents:
- Draft guidance on clinical trial applications for clinical trial sponsors (update),
- Draft guidance document for clinical trial sponsors: Sex and gender-based analysis (SGBA) plus demographics action plan in clinical trial applications (new), and
- Draft guidance on proposed new Clinical Trials Regulations (GUI-0100) (update).
The deadline for comments on the draft guidance documents and the draft Regulations is March 20, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
