Canada
Health Canada — Health Products and Food Branch (HC HPFB) · Americas
Executive summary
Canada operates a unified federal medicines regulatory system administered by the Health Products and Food Branch (HPFB) of Health Canada under the Food and Drugs Act and the Food and Drug Regulations. New drugs are approved through the New Drug Submission (NDS) pathway; biologics and radiopharmaceuticals are reviewed by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD); pharmaceutical drugs by the Therapeutic Products Directorate (TPD). Canada is a founding member of the ACCESS Consortium with TGA, MHRA, Swissmedic and HSA, providing collaborative regulatory review and work-sharing. Health Canada operates the 'Use of Foreign Reviews' policy enabling reliance on FDA, EMA, MHRA, and TGA assessment reports for selected submission types — particularly post-approval supplements and biosimilars. Project Orbis (oncology) provides parallel review with FDA, EMA, MHRA, TGA, Swissmedic, HSA and ANVISA. The pricing landscape changed materially in 2024 when amended Patented Medicine Prices Review Board (PMPRB) regulations took effect, removing the US and Switzerland from the international reference basket (PMPRB11 → PMPRB7) and removing pharmacoeconomic price tests. The pan-Canadian Pharmaceutical Alliance (pCPA) negotiates with manufacturers on behalf of provincial public drug programmes, with CADTH (now Canada's Drug Agency from 2024) providing health technology assessment.
About the authority
HPFB comprises the Therapeutic Products Directorate (TPD, pharmaceuticals), Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Marketed Health Products Directorate (MHPD, post-market surveillance), Veterinary Drugs Directorate (VDD), and the Office of Submissions and Intellectual Property. The Health Products and Food Branch Inspectorate conducts compliance and enforcement. The Public Health Agency of Canada (PHAC) handles vaccine procurement and immunisation policy.
International affiliations
Reliance & recognition
Canada operates the Use of Foreign Reviews policy plus participation in the ACCESS Consortium and Project Orbis. Joint reviews with FDA under the regulatory cooperation framework are common for oncology. MRAs with EU, UK, Switzerland, Australia and others enable acceptance of GMP inspection outcomes.