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In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR).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
The Federal Court of Appeal (FCA) has affirmed a Federal Court (FC) decision finding that the brand name of a biosimilar drug (BYOOVIZ) was confusingly similar with the brand name of a biologic drug (BEOVU), even
In October 2025, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Government of Ontario announced new pathways to accelerate the funding of new drugs for Canadians. Canada currently ranks last among G7 countries in providing patients with timely access
Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) recently launched a strategy to advance the appropriate use of prescription drugs and related products in Canada. According to the CDA-AMC, 1.9 million Canadian seniors regularly use at least 1
Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) has launched a consultation on advice for a national bulk purchasing strategy for prescription drugs and related products. Notably, the advice proposes making the pan-Canadian Pharmaceutical Alliance (pCPA)
On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB or Board) released the final version of its new guidelines (the Guidelines).
The Guidelines outline a new process for Board Staff to evaluate and make hearing
On June 19, 2025, Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) announced a consultation on a proposed list of essential prescription drugs and related products intended to inform the development of a national formulary. The consultation is
Health Canada has proposed a substantial change to the regulation of biosimilar drugs in Canada that may result in earlier applications for marketing authorization and earlier litigation under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Specifically