On December 20, 2025, Health Canada posted a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis.
This initiative aims to streamline processes, enhance regulatory efficiency, and improve access to new and innovative therapies for people in Canada by better supporting innovative trials throughout a trial’s life cycle — all while maintaining strong safety protections for participants. It comes as a follow-up to consultations that occurred five years ago.
The proposed new singular Clinical Trial Regulations will replace significant pieces of regulation found 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 Clinical Trials Regulations will apply to both authorized drugs and drugs that are not currently authorized in Canada. They will 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 clearly outline the overall requirements for all activities related to good clinical practices (GCP). Of note, the international Good Clinical Practice Guidelines E6R3 from the International Council for Harmonization will come into effect in Canada on April 1, 2026.
