Canada: Food and Drugs Law

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Teva And Samsung Bioepis Add Up To Six Biosimilar Candidates To Partnership
Teva Pharmaceutical Industries and Samsung Bioepis have expanded their biosimilar partnership to include up to six new biosimilar candidates. Two confirmed candidates are SB41, referencing AstraZeneca's FASENRA (benralizumab) for eosinophilic asthma, and SB44, referencing Novartis's ILARIS (canakinumab) for systemic juvenile idiopathic arthritis and other inflammatory conditions.
Canada Finance
GP
Goodwin Procter LLP
Article
Santé Canada Met À Jour Ses Politiques Concernant Les Mesures Réglementaires Étrangères, Les Rapports De Synthèse, La Conformité Et L’application De La Loi, Ainsi Que Les Demandes De Nouvelles Données
Santé Canada a publié plusieurs lignes directrices révisées et nouvelles politiques en septembre 2026, touchant les exigences de notification des mesures réglementaires étrangères, les rapports de synthèse pour les produits de santé, et l'application de la loi. Ces mises à jour clarifient les obligations des parties réglementées et introduisent un projet pilote pour les examens conjoints du Consortium Access.
Canada Healthcare
SB
Smart & Biggar
Article
Règlement Sur Les Médicaments Brevetés (Avis De Conformité) : Neuvième Anniversaire Des Modifications Majeures
Le 21 septembre 2026 a marqué le neuvième anniversaire des modifications importantes apportées au Règlement sur les médicaments brevetés (avis de conformité). Cet article examine les tendances des litiges pharmaceutiques au Canada, notamment le nombre record de faibles procédures engagées et l'absence de décisions sur le fond rendues par la Cour fédérale. L'analyse couvre également les actions en cours, les procédures sommaires et les dem
Canada IP
SB
Smart & Biggar
Article
Do Canadian Manufacturers Owe A Duty To Develop Safer Alternatives?
The British Columbia Court of Appeal has left open the possibility that pharmaceutical manufacturers may owe a duty of care to develop safer alternatives to their existing products, even when those products are properly approved and labeled. This decision in Gilead Sciences, Inc. v. I.F. contrasts sharply with a recent California Supreme Court ruling that rejected such a "duty to innovate," potentially setting Canada on a divergent path in product liability law.
Canada Litigation
TL
Torys LLP
Article
Peptides In Canada: Regulatory Reality Is Catching Up With The Hype
Health Canada's recent enforcement action against unauthorized injectable peptides signals a regulatory shift that wellness companies cannot afford to ignore. While peptides dominate influencer marketing and online wellness spaces, their legal status in Canada depends on factors far more complex than social media trends suggest. Understanding how route of administration, therapeutic claims, and market authorization intersect is now critical for compliance.
Canada Consumer
GW
Gowling WLG
Article
Distilled Law, Part 1: Whisky Business: Alberta's New Spirit Standards And The Future Of AI Use In Legislative Drafting
The Government of Alberta has reportedly become the first jurisdiction in Canada to use artificial intelligence (“AI”) in the initial drafting of the Alberta Whisky Act (the “Whisky Act”). The Whisky Act, which came into effect on May 21, 2026, establishes new standards and definitions for what qualifies as “Alberta Whisky”, including requirements relating to production standards, ingredients, and processes. According to the province, AI was used as part of the drafting process, with government officials and legislative counsel retaining responsibility for review, revision, and all levels of approval.
Canada Healthcare
F
Fasken
Article
Health Canada Launches New Clinical Trial Search Portal And Publishes Updated Guidance
Health Canada has launched a new Clinical Trial Search Portal and released updated guidance on clinical trial registration and public disclosure of results. The portal provides searchable information on Health Canada-authorized clinical trials for pharmaceutical, biologic and radiopharmaceutical drugs, while the guidance outlines expectations for sponsors regarding trial registration and summary result reporting.
Canada Healthcare
SB
Smart & Biggar
Article
Entering The Canadian Market: Key Regulatory And Compliance Considerations For Whisky And Spirits
Canada's whisky and spirits market presents significant opportunities for international producers, but success requires careful navigation of a dual regulatory framework. Federal laws govern production standards, excise duties, and labelling requirements, while each province maintains its own liquor authority controlling distribution, sales, marketing, and pricing within its borders. Understanding these overlapping jurisdictions and tailoring market entry strategies to provincial variations is essential for
Canada Consumer
AB
Aird & Berlis LLP
Article
Canada’s Proposed Food Packaging Framework Would Require Notification Of FCMs
Health Canada has launched a public consultation on a proposed mandatory food packaging framework that would require notifications for all food contact materials sold in Canada. The initiative aims to enhance oversight of chemical exposures through a new knowledgebase system that cross-references submitted information against evaluated materials, with a five-year phase-in period anticipated following regulatory development.
Canada Consumer
BC
Bergeson & Campbell
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