Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

Pharmaceutical and veterinary drug manufacturers — primarily multinational companies with products already approved by recognized foreign regulators — can now choose to file submissions in Canada using three pathways: relying on an existing foreign approval (General Deeming), filing in Canada within 120 days of a foreign filing to get a head start on review (120-Day Filing), or leveraging joint review reports (Joint Reviews). Each submission using deeming will cost roughly $1,150 to demonstrate eligibility, plus an average of $8,450 to document any differences between the Canadian and foreign versions of the drug — totalling about $9,600 per filing at minimum. In exchange, manufacturers can expect roughly 1.5 fewer back-and-forth information requests per submission, saving an estimated $18,450 per avoided request. Canadian small businesses (under 100 employees or under $5 million revenue) are unlikely to benefit, as they typically lack a prior foreign regulatory decision to rely on, and some domestic manufacturers have raised concerns about increased competition from multinationals using this streamlined pathway.