Without much fanfare, Health Canada announced in the Canada Gazette Part 1 on Dec. 22, 2025 that it was beginning a 70-day consultation period on using the decisions of foreign drug regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve new drugs in Canada.
If the proposal is approved, Health Canada will evaluate reports from the other regulators, and provided those reports are satisfactory and that the drugs met certain conditions (for example, the drug being considered by Health Canada has the same strength, dosage form, route of administration, medicinal ingredient and indications as the foreign drug), the new drug will be approved.
This announcement appears to be a continuation of the federal government’s Red Tape Review launched in July 2025. According to a report on this initiative, Health Canada’s rationale for this change is that “industry stakeholders have indicated that they face undue burden due to overlapping or unclear regulatory requirements, complex regulatory approvals, and onerous reporting and information demands” and have “raised concerns about the time it takes to get products to market.”
