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

Photo of Sarah PenningtonPhoto of Paul JorgensenPhoto of Kristin Wall
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…

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Photo of Sarah PenningtonPhoto of Kristin Wall
By Sarah Pennington & Kristin Wall on August 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to…

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