Regulatory Reliance: A step in the right direction, but Health Canada can afford to be bolder

Launched earlier this month, Health Canada’s consultation on the final elements of its forthcoming regulatory reliance approach marks an important development in Canadian drug regulation. Expected to take effect later this year, the new mechanism would allow Health Canada to make use of trusted foreign regulatory decisions in drug approvals, while retaining Canadian decision-making authority.

This is a meaningful step. It reflects a growing reality in global medicines regulation: regulators increasingly collaborate, share expertise, and are building confidence in one another’s scientific assessments. The proposal also raises a broader question: is Canada fully using the opportunity that regulatory reliance presents?

Health Canada’s proposed approach is cautious. The initial rollout would apply to a relatively narrow group of products, including pediatric drugs, veterinary medicines, and products undergoing joint international reviews. Standard submission requirements, fees, and review timelines would largely remain in place.

That design may support careful implementation, but it also raises practical questions. If the filing requirements closely resemble a conventional review process, manufacturers may rightfully ask what advantages this offers.

Canada’s exploration of regulatory reliance is not new. Health Canada established formal policies concerning the use of foreign reviews more than a decade ago, conducted a pilot project in the early 2010s, and identified expanded reliance mechanisms in subsequent policy and regulatory planning. Viewed over this longer timeline, the current proposal appears less as a new departure than as another small incremental advance.

At the same time, Canada’s own experience demonstrates that greater flexibility is possible.

Over the past decade, Health Canada has repeatedly relied on foreign-approved products to respond to urgent needs. A pathway addressing urgent public health needs was created in 2017; and during the COVID-19 pandemic, exceptional measures allowed access to certain foreign-authorized drugs and medical devices. Similar authorities were used to respond to infant formula shortages.

These measures arose from exceptional circumstances, but they illustrate an important point: Canada has already shown a willingness to rely on trusted foreign regulatory systems when domestic needs require it – all without sacrificing safety.

Meanwhile, international regulatory collaboration has expanded significantly. Health Canada now participates in initiatives such as Project Orbis and the ACCESS Consortium, working alongside peer regulators in scientific reviews, and even more so in areas related to manufacturing oversight and inspections. Mutual understanding of regulatory processes, evidentiary standards, and review practices continues to deepen.

Against that backdrop, the policy challenge really isn’t whether reliance is feasible, but how to design it effectively.

There has to be a productive middle ground between duplicating full domestic reviews of products already assessed by trusted regulators and relying on broad emergency importation mechanisms. A modern reliance pathway would preserve Canadian oversight while reducing unnecessary procedural duplication.

If Canada were to pursue a more ambitious model, several options stand out. A streamlined submission package, reduced fees, and shorter review timelines would better align the pathway with its intended purpose and with approaches adopted by key peer regulators. Broader eligibility criteria could also increase the pathway’s practical value.

One area where this could be particularly meaningful is rare disease therapies. Canada still does not have a comprehensive regulatory framework specifically tailored to rare disease drugs. A reliance pathway could help address this gap — for example, by permitting therapies with foreign orphan designation or approval from trusted regulators such as the U.S. Food and Drug Administration, the European Medicines Agency, or Australia’s Therapeutic Goods Administration to qualify for a specialized Canadian reliance process.

Regulatory reliance is not about outsourcing judgment or lowering standards. It is about recognizing the increasingly interconnected nature of medicines regulation and using international cooperation to improve efficiency, timeliness, and patient access while maintaining confidence in Canadian oversight.

Health Canada’s proposal represents an important foundation. The remaining question is whether Canada intends to use this tool as a limited procedural option, or as part of a broader modernization of drug regulation in an increasingly interconnected regulatory environment.