Health Canada is seeking feedback on the proposed Clinical Trials Regulations for drugs (pharmaceuticals, biologics and radiopharmaceuticals) and on multiple guidance documents related to the proposal. The proposed framework would replace the clinical trial regulatory schemes for drugs in the following sections of the regulations:
Part C, Division 5 of the Food and Drug Regulations and
Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
This proposed framework aims to improve access to new and innovative therapies for people in Canada while maintaining strong safety protections for participants.
This initiative is part of Health Canada and the Public Health Agency of Canada’s work to streamline processes and enhance regulatory efficiency.
The consultation is open until March 20, 2026.
- For more information visit: Government of Canada
- To read a legal discussion about this visit: Pharmain Brief
- To read the official announcement visit: Government of Canada Gazette