Update: The deadline for comments on the draft guidance documents and the draft Regulations has been extended to April 19, 2026 (previously March 20, 2026).
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Health Canada has also released three associated draft guidance documents:
- Draft guidance on clinical trial applications for clinical trial sponsors (update),
- Draft guidance document for clinical trial sponsors: Sex and gender-based analysis (SGBA) plus demographics action plan in clinical trial applications (new), and
- Draft guidance on proposed new Clinical Trials Regulations (GUI-0100) (update).
The deadline for comments on the draft guidance documents and the draft Regulations is March 20, 2026.
Update: On December 23, 2025, Health Canada separately launched a consultation on a draft guidance on decentralized clinical trials. The draft guidance relates to current regulatory requirements and other considerations for decentralized clinical trials, where some or all trial-related activities take place at locations other than traditional clinical trial centres. The draft is an interim measure that will be updated to reflect the above new regulations once in force. The deadline for comments is February 21, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.