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National Pharmacare: Canada’s Drug Agency Consulting on National Bulk Purchasing Strategy

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on July 14, 2025

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)…

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Drug Pricing Update: PMPRB releases final price-review Guidelines

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By Christopher A. Guerreiro & Kristin Wall on July 1, 2025

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…

National Pharmacare: Canada’s Drug Agency Consulting on List of Essential Prescription Drugs

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on June 24, 2025

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

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By Paul Jorgensen, Pardeep Heir & Kristin Wall on June 20, 2025

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…

Federal Court upholds patent validity and issues injunction and delivery up order against biosimilar

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By William Chalmers, Christopher A. Guerreiro & Kristin Wall on May 25, 2025

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…

Canada expanding national pharmacare and rare disease drug coverage

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 27, 2025

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

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 7, 2025

On March 6, 2025, British Columbia became the second province to announce the signing of a pharmacare agreement with Canada’s federal government. Manitoba was the first province to do so, on February 27, 2025 (our report here).

British Columbia’s

…

Agile licensing, risk, biologics, and more: Wide-ranging amendments to Canada’s drug and medical device regulations

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 3, 2025

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…

National pharmacare in Canada: First-ever funding agreement announced

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on February 27, 2025

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.

Pharmacare

…

Drug shortages: New requirements proposed for the Food and Drug Regulations

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By Julia Kafato, Sarah Pennington, Paul Jorgensen & Kristin Wall on February 12, 2025

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…

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