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Health Canada Comment Period

Smart & Biggar

Proposed Ministerial Reliance Order would allow Health Canada to rely on decisions of foreign trusted regulators

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On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance Order and (ii) clinical...more

Smart & Biggar

Proposal for modernizing clinical trial framework aims to improve access to new and innovative therapies in Canada

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On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. This...more

Bennett Jones LLP

Health Canada Proposes Amendments to MDEL Holders and Applicants

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On November 8, 2025, the Department of Health published proposed amendments to the Medical Devices Regulations, SOR/98-282 (MDR) with a specific focus on the medical device establishment licence (MDEL) regime. The proposed...more

Smart & Biggar

Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

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UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

Smart & Biggar

Health Canada publishes notice of consultation for proposed amendments to the Medical Devices Regulations

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On January 7, 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations. The notice of consultation (i) advises of the notice of intent published on December 11, 2021...more

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Health Canada Consultation on Electronic Media in Prescription Drug Labelling

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On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more

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