Canada

Health Canada is the federal department responsible for regulating health products in Canada, operating under the authority of the Food and Drugs Act (R.S.C., 1985, c. F-27) and its associated regulations, including the Food and Drug Regulations, the Medical Devices Regulations (SOR/98-282), and the Natural Health Products Regulations. All health products, including pharmaceuticals, biologics, medical devices, in vitro diagnostics, and natural health products, must receive a Health Canada authorization before they can be marketed in Canada. Pharmaceuticals require a New Drug Submission (NDS) or Abbreviated New Drug Submission (ANDS) resulting in a Notice of Compliance (NOC), while medical devices are classified into four risk-based classes (Class I through Class IV) with progressively rigorous review requirements. Digital health technologies and Software as a Medical Device (SaMD) are assessed under the Medical Devices Regulations when they meet the definition of a device. Health Canada has also developed a Progressive Licensing Framework to enable more adaptive, lifecycle-based oversight of health products.

Health Canada accepts submissions prepared in accordance with the International Council for Harmonisation (ICH) Common Technical Document (CTD) format for pharmaceuticals and biologics, aligning Canada closely with international regulatory standards. Foreign manufacturers are not required to have a physical presence in Canada but must designate a Canadian Importer of Record or a licensed distributor responsible for regulatory compliance. Medical device manufacturers must hold or be associated with a Medical Device Establishment Licence (MDEL). Notable recent reforms include the introduction of the Agile Licensing Project, expanded use of collaborative and work-sharing reviews with partner agencies such as the FDA, EMA, TGA, and Swissmedic through the Access Consortium and Project Orbis, and ongoing modernization efforts under Bill C-64 and the Strengthening Health Canada's Drug Regulatory System initiative. Health Canada has also expanded its real-world evidence guidance and is actively developing a regulatory framework for advanced therapeutic products.

Canada operates under a federated procurement structure in which both the federal government and the thirteen provincial and territorial governments play significant roles in the acquisition of health products. The federal government, through Health Canada, the Public Health Agency of Canada (PHAC), and Public Services and Procurement Canada (PSPC), manages procurement for federal programs, national stockpiles, Indigenous health services, and military health. However, the majority of publicly funded health product procurement occurs at the provincial and territorial level, as each province and territory administers its own public drug plan and health authority purchasing system. Provincial ministries of health and regional health authorities issue tenders, negotiate formulary listings, and contract with suppliers independently, meaning manufacturers must often engage in multiple parallel negotiations across jurisdictions. Pan-Canadian collaboration is facilitated through the Canadian Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR), both conducted by the Canadian Drug Review body known as CADTH (Canada's Drug Technology in Health), which provides evidence-based reimbursement recommendations to provincial and territorial drug plans. The pan-Canadian Pharmaceutical Alliance (pCPA) conducts joint price negotiations on behalf of participating public drug plans to improve affordability and consistency.

The private sector represents a significant procurement channel in Canada, encompassing employer-sponsored private drug plans, out-of-pocket purchases, and specialty pharmacy networks. Private insurers and pharmacy benefit managers (PBMs) negotiate independently with manufacturers and maintain their own formularies, creating a parallel market alongside the public system. Canada does not typically rely on multilateral donor-funded procurement mechanisms such as UNICEF Supply Division, the Global Fund, or USAID, as it is a high-income donor country rather than a recipient. However, Canada contributes funding to global health initiatives and may procure products through these channels for international development or humanitarian programs administered by Global Affairs Canada. Local manufacturing preference policies have gained renewed attention following supply chain vulnerabilities exposed during the COVID-19 pandemic, prompting the federal government to invest in domestic biomanufacturing capacity through initiatives such as the Biomanufacturing and Life Sciences Strategy and funding to organizations like the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). While formal domestic preference requirements in procurement are limited under Canada's trade agreement obligations, including CUSMA and CPTPP, strategic investments and advance purchase agreements increasingly favor suppliers with Canadian manufacturing or supply chain linkages.