Canada: Food and Drugs Law

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Article
Teva And Samsung Bioepis Enter Into Commercialization Agreement For OPUVIZ In Canada
Teva Pharmaceutical Industries and Samsung Bioepis have announced a strategic partnership to commercialize OPUVIZ, a biosimilar referencing EYLEA, in the Canadian market. The agreement divides responsibilities between Samsung Bioepis handling product registration and manufacturing while Teva Canada leads commercialization efforts. OPUVIZ has already received Health Canada approval for treating multiple eye conditions including wet age-related macular degeneration and diabetic macular edema.
Canada Healthcare
GP
Goodwin Procter LLP
Article
The More Things Change, The More They Stay The Same: The Supreme Court Determines The Patentability Of Methods Of Medical Treatment
The Supreme Court of Canada has issued its most significant ruling on medical treatment patents in over fifty years, addressing whether dosing-regimen claims for schizophrenia medication constitute unpatentable methods of medical treatment. The 7-2 decision establishes a new framework for evaluating pharmaceutical patents, focusing on whether implementing the claimed invention requires professional medical skill and judgment. This landmark case provides crucial guidance for life sciences companies seeking p
Canada IP
C
Cassels
Article
Bill C-30 Amendments To The Pest Control Products Act And Canadian Food Inspection Agency Act
Parliament has enacted Bill C-30, introducing significant amendments to Canada's Pest Control Products Act and Canadian Food Inspection Agency Act that grant Cabinet unprecedented authority to issue emergency orders overriding pesticide safety decisions. These new powers allow the government to temporarily authorize pesticide use or reinstate cancelled registrations based on national economic security and food security considerations, even when environmental risks are deemed unacceptable. The legislative ch
Canada Environment
TL
Torys LLP
Article
Canada’s Amended Medical Devices Regulations: What Will Change In December
Canada's federal government has finalized amendments to the Medical Devices Regulations, introducing significant changes to medical device establishment licensing requirements. These modernized regulations eliminate the need for foreign distributors to hold separate licenses when selling through licensed Canadian importers, mandate supplier list disclosure to Health Canada, and establish explicit documentation requirements for safety-management procedures.
Canada Consumer
TL
Torys LLP
Article
Health Canada Finalizes Biosimilar Guidance: Comparative Clinical Efficacy Studies Not Typically Required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016. Such guidance had, in most cases, required comparative clinical efficacy and safety trials between the biosimilar and reference product. In 2025, Health Canada consulted on a revised draft guidance document for biosimilar submissions, which notably proposed removing the requirement for comparative clinical efficacy and safety trials.
Canada Healthcare
SB
Smart & Biggar
Article
Health Canada Seeks Feedback On Phased Implementation Of The Incorporated By Reference List For Ministerial Reliance Order
As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed that the Reliance Order will come into force in summer 2026, at which point Health Canada will consult on an applicable guidance document.
Canada Healthcare
SB
Smart & Biggar
Article
Le problème des DIN dormants au Canada : comment le statut de commercialisation sape les protections de la PI pharmaceutique prévues à l’ACEUM
Le Canada a ratifié l'Accord Canada–États-Unis–Mexique avec un engagement envers un cadre de propriété intellectuelle stable pour l'innovation pharmaceutique. Cependant, le traitement des numéros d'identification de médicament (DIN) « dormants » crée une incertitude réglementaire qui lie les protections de PI au statut de commercialisation plutôt qu'à l'approbation réglementaire. Cette approche soulève des questions sur la con
Canada Healthcare
MT
McCarthy Tétrault LLP
Article
L’Agence des médicaments du Canada publie une mise à jour des procédures relatives aux examens en vue du remboursement et de nouvelles données sur les délais d’évaluation des technologies de la santé
L'Agence des médicaments du Canada a publié des mises à jour importantes concernant les procédures d'examen en vue du remboursement, introduisant un processus simplifié de 180 jours et des critères révisés pour les reconsidérations et nouvelles demandes.
Canada Healthcare
SB
Smart & Biggar
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