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Smart & Biggar | Canada | 18 May 2022

CADTH proposals to enhance drug review processes

The Canadian Agency for Drugs and Technologies in Health recently held consultations on two new proposals: a proposed process for non-sponsored reimbursement reviews and a streamlined process for drug class reviews. The former is intended to apply to scenarios where a sponsor is unwilling or unable to file an application, while the latter would provide a new streamlined drug class review......
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Bereskin & Parr LLP | Canada | 27 Apr 2022

Competition Bureau and Health Canada to cooperate to facilitate competition

The Competition Bureau and the Health and Food Products Branch of Health Canada (HFPB) issued a joint notice in January 2022, announcing their…
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Smart & Biggar | Canada | 20 Apr 2022

New guidance documents and regulatory amendments regarding therapeutic product shortages

In response to the covid-19 pandemic, the minister of health made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and 2021. In anticipation of the expiry of Interim Order No. 2, the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the Regulations) were promulgated in 2021. Various......
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Smart & Biggar | Canada | 2 Mar 2022

Restricted drugs now possible through SAP

Amendments to the Food and Drug Regulations recently came into force to allow practitioners to request access to restricted drugs through the special access programme, which was previously prohibited. "Restricted drugs" are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations, which includes, for example, certain amphetamines and lysergic acid......
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Smart & Biggar | Canada | 2 Mar 2022

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

Health Canada has issued a notice of consultation for proposed amendments to the Medical Devices Regulations. The proposed amendments would streamline medical device establishment licence (MDEL) holders' application requirements to reflect existing practices, provide the Minister of Health with new and expanded authorities over MDELs, and implement ministerial authority to order recalls of......
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Smart & Biggar | Canada | 23 Feb 2022

Competition Bureau's interest in health sector continues

Promoting competition and innovation in Canada's health sector, including the pharmaceutical industry, is a strategic priority for the Competition Bureau. Given the Bureau's interest in healthcare, those in the industry (especially the pharmaceutical industry) will want to keep potential antitrust considerations in mind when engaging in any activity.
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Smart & Biggar | Canada | 9 Feb 2022

Pan-Canadian Formulary Advisory Panel holds information session on proposed framework for potential pan-Canadian formulary

The Pan-Canadian Formulary Advisory Panel recently presented an information session with its recommendations for the development of a framework for a potential pan-Canadian prescription drug list, or formulary. The information session focused on the principles for developing a pan-Canadian formulary framework, a sample list of prescribed drugs to include on the potential formulary as a test......
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Smart & Biggar | Canada | 9 Feb 2022

2021 highlights in Canadian life sciences IP and regulatory law

This article provides an overview of the top Canadian life sciences IP and regulatory law developments in 2021, including various patent decisions issued by the Federal Court and the Federal Court of Appeal and updates relating to Health Canada, biosimilars and the Patented Medicine Prices Review Board.
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Smart & Biggar | Canada | 19 Jan 2022

Federal Court of Appeal dismisses appeal and upholds strict interpretation of patent listing deadline for Keytruda formulation patent

In a recent case, the Federal Court of Appeal dismissed an appeal by Merck from a decision of the Federal Court dismissing Merck's application for judicial review of Health Canada's refusal to add Canadian Patent No. 2,830,806 to the Patent Register. Merck would need leave from the Supreme Court of Canada to appeal this decision.
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Smart & Biggar | Canada | 12 Jan 2022

Health Canada paving the way for more AI/ML medical devices

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Recently, Health Canada, the US Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency jointly published the Good Machine Learning Practice for Medical Device Development: Guiding......
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