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Regulatory Reform Canada Prescription Drugs

Smart & Biggar

Updated PMPRB Guidelines expected in summer 2025 and NPDUIS releases ninth edition of the Meds Entry Watch Report

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In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

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On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

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Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Smart & Biggar

Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

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