Health Canada Launches Foreign Drug Review Framework
The new framework allows Health Canada to use foreign regulatory work for eligible submissions while maintaining Canadian-specific review requirements and final approval authority.
A new foreign drug review framework now allows Health Canada to rely on decisions and documents from selected international regulators when assessing certain human and veterinary drugs.
The Ministerial Reliance Order, which came into force on July 15, 2026, allows the Minister of Health to treat specified parts of an eligible drug submission as already examined based on work completed by a listed foreign regulatory authority. This process is known as deeming.
The order may apply to non-clinical, clinical, and chemistry and manufacturing information.
Health Canada has opened a 60-day consultation on draft guidance, with comments accepted until September 12.
The foreign drug review framework establishes three pathways through which manufacturers bringing products to Canada can seek deeming:
Eligibility is determined through separate incorporated-by-reference lists for human and veterinary drugs.
The initial human drug list includes selected pediatric medicines, tuberculosis treatments, therapies for certain rare diseases, and other products intended to address unmet medical needs.
Eligible regulators for human drugs include authorities in the United States, European Union, United Kingdom, Switzerland, and Australia, along with Singapore in a more limited set of cases.
The veterinary drug list applies to a broader range of submissions and draws on a set of regulators, including authorities in Australia, the European Union, New Zealand, the United Kingdom, and the United States.
Health Canada has indicated that generic and biosimilar drugs are not a focus of the initial framework and will be considered in a future phase of implementation.
At Cole International, we offer trade consulting and customs brokerage services to help Canadian businesses navigate documentation, classification, and compliance requirements for regulated shipments.
If you import any of the listed products into Canada, reach out to one of our trade professionals to discuss the customs requirements that may apply to your shipments.