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
The Federal Court (FC) has upheld the validity of a patent concerning a biologic drug used to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, in an infringement action under section 6 of
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
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
On February 27, 2025, the governments of Canada and of the Province of Manitoba announced the first-ever national pharmacare funding agreement. The two governments also announced a funding agreement under the National Strategy for Drugs for Rare Diseases.
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