Canada: Food and Drugs Law

Le Groupe de travail sur le secteur des produits pharmaceutiques et des sciences de la vie a publié son rapport final identifiant les défis structurels du Canada en matière d'accès aux médicaments, d'innovation et de compétitivité. Le rapport formule 39 recommandations urgentes visant à moderniser les processus réglementaires, accélérer le remboursement des médicaments innovants et renforcer l'écosystème canadien des sciences de la vie.

The Supreme Court of Canada has issued a landmark ruling on whether methods of medical treatment can be patented in Canada, addressing a long-standing prohibition that has shaped the country's intellectual property landscape. The decision examines the boundaries between patentable medical innovations and unpatentable professional medical judgment, with particular focus on dosing regimens and treatment protocols. This ruling provides critical guidance for pharmaceutical companies, patent practitioners, and h

Health Canada has finalized revised guidelines that fundamentally shift biosimilar drug approval away from comparative clinical efficacy studies toward an analytical-comparability-driven framework.