On December 20, 2025, Health Canada announced draft Clinical Trial Regulations (CT Regulations) and related guidance that would revamp how clinical trials are regulated in Canada. The draft regulations are intended to clarify and simplify existing rules and establish a modernized framework of flexible, risk-based oversight to better support innovative trials, reduce regulatory burden, and enhance participant access and safety.
According to Health Canada, this more flexible and internationally aligned framework would also attract global investment, increase research capacity, and expand access to new therapies. Health Canada is accepting feedback on the draft CT Regulations and related guidance documents until March 20, 2026.