Health Canada to rely on some foreign drug approvals, possibly including the U.S. FDA
Health Canada’s draft ministerial order would let the regulator use decisions from trusted foreign authorities to speed some approvals. The move has industry backing and expert concerns.
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By Torontoer Staff
Health Canada published a draft ministerial order that would let it rely on decisions by trusted foreign drug regulators to speed up some approvals, and officials have not ruled out including the U.S. Food and Drug Administration on that list.
The order, part of a federal push to cut red tape, outlines three ways Canada could 'piggyback' on foreign reviews. A public consultation on the proposal runs until Feb. 28.
How the draft order would change approvals
The draft ministerial order lays out three potential pathways for relying on trusted foreign regulators. In some cases Health Canada could treat parts of a submission as already completed if a foreign regulator has approved the same product. In another scenario, Health Canada could use elements of in-progress reviews conducted by other authorities, provided companies file in Canada within 120 days of their foreign application. The third option would expand joint reviews with other regulators.
- Recognize parts of a submission as complete when a trusted regulator has approved the drug
- Draw on in-progress foreign reviews if Canadian filing follows within 120 days
- Conduct more joint reviews with other regulators
Which regulators and which drugs are under consideration
The draft does not name the initial list of trusted foreign regulators or the exact drug classes that would be eligible. Health Canada said selections will be based on established partnerships and comparable regulatory standards, and the department may modify the list over time.
Health Canada will make decisions on which regulatory authorities it can rely on based on established partnerships and comparable regulatory standards. The department will also be able to modify the list of trusted regulatory authorities as appropriate.
André Gagnon, Health Canada spokesman
The draft notes that countries such as Australia, Switzerland, Britain and Singapore use pathways that rely in part on foreign decisions. Examples of drug classes flagged as possibilities for early inclusion are veterinary drugs, medicines for food-producing animals and paediatric formulations.
Industry support and government rationale
Ottawa says the change responds to a rise in the number and complexity of pharmaceutical submissions and complaints from industry and some patients about approval delays. Health Canada recorded a 43 per cent increase in new generics applications since 2016.
Industry groups have expressed broad support for faster, more efficient reviews. The Canadian Generic Pharmaceutical Association urged prioritizing timely approvals of cheaper generics to help lower medication costs. The Canadian Veterinary Medical Association said it was encouraged by the draft order, noting long-standing concerns about shortages and slow approvals for veterinary products.
Concerns from experts about standards and capacity
Some health law experts warned that relying on foreign decisions could reduce the redundancy that helps catch differences in safety and effectiveness assessments across regulators, and create pressures to shrink Canada’s own reviewer workforce.
If you look at decisions by the EMA versus FDA versus Health Canada, you actually see a lot of nuance. And in a time as volatile as we’re living in, I actually think you want redundancies in the system, not one gatekeeper effectively, which is what this could lead to.
Matthew Herder, director, Health Law Institute, Dalhousie University
Herder said he would be particularly concerned if the current incarnation of the U.S. FDA were included. The agency faces staffing changes and leadership shifts that critics say have affected priorities.
Others see a potential benefit if the approach encourages companies to file in Canada for products already authorised overseas, including child-friendly formulations of certain treatments.
Health Canada is pretty good at being the bouncer at the nightclub. But if there’s something really good that we want to have, they can’t drag you inside.
Adam Houston, adjunct professor of health law, University of Ottawa
Next steps and what to watch for
The consultation period closes on Feb. 28. Observers will be watching which foreign regulators appear on the initial list and which drug classes are prioritised. The final order will determine how much of Canada’s evaluation work will be replaced or supplemented by foreign reviews, and whether the change will speed access without compromising independent assessment.
The debate frames a broader choice about regulatory trade-offs: faster access to medicines, and potentially lower costs, versus preserving independent review capacity and the redundancy that can catch differences in scientific judgment.
Stakeholders including industry groups, medical associations and public interest organisations can submit feedback during the consultation. Health Canada says it will base any final decisions on comparable standards and existing partnerships.
Health Canadadrug approvalsFDApharmaceuticalsregulation
