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Health Canada Regulatory Reform

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

Health Canada consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug...

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As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations (FDRs). The amendments included authorities that will come into force on April 1, 2027,...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

Blake, Cassels & Graydon LLP

Consultation sur les modifications proposées aux exigences relatives aux licences d’établissement d’instruments médicaux

Le 8 novembre 2025, Santé Canada a publié le Règlement modifiant le Règlement sur les instruments médicaux (licences d’établissement) (le « projet de règlement ») dans La Gazette du Canada, lequel propose des changements aux...more

Blake, Cassels & Graydon LLP

Santé Canada et l’Agence de la santé publique du Canada publient un rapport sur la réduction du fardeau administratif

En réponse aux préoccupations des parties prenantes au sujet des processus administratifs obsolètes et trop prescriptifs, le gouvernement du Canada a lancé un examen du fardeau administratif dans tous les ministères et...more

Blake, Cassels & Graydon LLP

Health Canada and the Public Health Agency of Canada Release Report on Cutting Red Tape

In response to stakeholder concerns about outdated and overly prescriptive administrative processes, the Government of Canada launched a review of administrative burdens (referred to as “red tape”) across all federal...more

Smart & Biggar

Health Canada aims to reduce red tape by increasing international collaboration, alignment and reliance

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In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth. In this context, Health Canada and the Public Health Agency of...more

ArentFox Schiff

RFK Jr. Sets Sights on Currently Authorized Synthetic Food Dyes

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On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the...more

Smart & Biggar

Health Canada publishes guidance on submitting risk management plans

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As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more

DLA Piper

Food and Beverage News and Trends - February 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Jim Jones, Deputy Commissioner for Human Foods at the US Food and Drug...more

Smart & Biggar

Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages

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On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...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

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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