On March 5, 2026, the Patented Medicine Prices Review Board (PMPRB or Board) published a series of proposed Practice Directions to streamline its hearing process. The proposed Practice Directions signal an important procedural shift away from live in-person
Health Canada has proposed a framework under which manufacturers can ask it to rely on foreign regulatory decisions to speed up the review of new drug submissions. The framework, which would apply to new drugs in certain classes, is intended
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
The Pharma in Brief team is looking back at 2025’s most notable legal and regulatory developments in the Canadian pharmaceutical space and highlighting hot topics for 2026. To those who don’t make it to the end of the article, we’ll
In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR). The related FDR