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In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR).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
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
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
Health Canada has proposed additional regulations intended to prevent, mitigate, and respond to drug shortages. The proposed amendments to the Food and Drug Regulations (Regulations) include new requirements for drug market authorization holders to develop shortage prevention and
2024 saw no shortage of headlines in the Canadian pharma space. Here we look back on the year’s most notable legal and regulatory developments and look forward to areas to watch in 2025.
In
The Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with
The Federal Court of Appeal (FCA) has confirmed that the Patented Medicine Prices Review Board (PMPRB or Board) does not have jurisdiction over the prices of unpatented medicines. In doing so, the FCA overturned decisions of