Report shows average wait time significantly longer than US
Canadians wait significantly longer than Americans and Europeans to access new medicines, according to a report released by the Fraser Institute examining drug approvals between 2019 and 2025.
“Innovative new medicines can have a profound impact on the health and wellbeing of those suffering from illness. Unfortunately, Canadians are often denied these benefits for months, if not years, waiting for government to approve drugs already deemed safe and effective by regulators in the European Union and United States,” said Kristina Acri, senior fellow at the Fraser Institute and author of Timely Access to New Pharmaceuticals in Canada, the United States, and the European Union.
The study, co-authored by Lauren Asaad, found that of the 194 drugs approved in both Canada and the United States during this period, approval was granted an average of more than 90 weeks earlier in the United States. Of the 174 drugs approved in both Canada and Europe, approval was granted an average of 65 weeks earlier in Europe.
Submission delays drive gap
The report identified submission timing as the primary contributor to delayed access. The lag suggests drug companies are reluctant to launch new drugs in Canada because of factors ranging from Canada’s smaller market size to weaker intellectual property protections and strict federal pricing policies.
“In some cases, pharmaceutical companies will wait up to a year after a drug has been approved in the US or Europe before submitting that same drug for approval in Canada,” Acri said. “Canada’s current approach, which duplicates approval processes undertaken in the US and Europe, imposes considerable delays on Canadians struggling with illness.”
Health Canada demonstrated greater efficiency than the European Medicines Agency in processing approvals after submission, making up an average of 42 days in the review process. However, the agency lagged behind the US Food and Drug Administration by an average of 50 days in processing efficiency.
Health and economic consequences
The delays carry significant consequences for Canadian patients and the health-care system, the researchers highlighted. According to the report, newer medicines are associated with increased longevity, better adherence to treatment, and lower overall health-care costs.
“Within the existing system, Canadians experience worse health outcomes and have access to fewer therapeutic options,” the study noted. “In addition, Canadians face higher health-care costs as a direct result of the mismanagement and delays in the drug approval processes.”
The analysis also revealed that 145 drugs approved by the FDA and European regulators between 2019 and 2025 never received approval in Canada, further limiting therapeutic options for Canadians.
Key to easier access
The authors recommended implementing mutual recognition agreements with US and European regulators to streamline the approval process while maintaining safety standards.
“In the absence of international agreements to recognize drug approvals, policymakers should carefully consider how Canada’s drug policies attract or discourage drug companies from entering the Canadian market,” Acri said.
Regulatory trends suggest a broader effort to streamline processes. Canada and Switzerland agreed in early 2025 to expand the scope of their Mutual Recognition Agreement on good manufacturing practices, allowing recognition of extra-jurisdictional inspections and extending cooperation on active pharmaceutical ingredient and plasma-derived product evaluations.
