In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR).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
Federal Court of Appeal affirms trademark confusion between names of eye medicines
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
Accelerating drug access in Canada: New pathways from the pCPA and Province of Ontario
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
Pharmacare update: Canada’s Drug Agency launches Appropriate Use Strategy
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
National Pharmacare: Canada’s Drug Agency Consulting on National Bulk Purchasing Strategy
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)
National Pharmacare: Canada’s Drug Agency Consulting on List of Essential Prescription Drugs
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
Biosimilar drugs will no longer need phase 3 clinical trials: Proposed changes from Health Canada
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
Canada expanding national pharmacare and rare disease drug coverage
March 2025 saw a flurry of developments in Canada’s emerging national funding systems of drugs for rare diseases and pharmacare. All of Canada’s 13 provinces and territories have now reached bilateral agreements with the federal government to cover certain drugs
British Columbia becomes second province to sign pharmacare agreement
Agile licensing, risk, biologics, and more: Wide-ranging amendments to Canada’s drug and medical device regulations
Canada has made wide-ranging amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR). The amendments are intended to deliver on Health Canada’s modernization commitments, codify long-standing policies and practices, and implement