On July 15, 2026, Health Canada's Ministerial Reliance Order Providing for Reliance on Decisions of, or Documents produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (“MRO”) came into force, marking a significant shift in the way certain drug submissions may be reviewed in Canada. On the dame day, Health Canada published a new draft guidance that provides the first detailed explanation of how the framework will operate in practice. A 60-day public consultation period, during which Health Canada is seeking feedback from industry stakeholders, is open until September 12, 2026.
What is the MRO?
Under the MRO, Health Canada may, in certain circumstances, rely on decisions or review documents produced by specified foreign regulatory authorities (“FRAs”) when reviewing eligible human and veterinary drug submissions. While Health Canada retains full authority for Canadian approval decisions, the framework introduces a mechanism through which portions of the review process can be deemed to have already been satisfied based on work performed by trusted international regulators.
More specifically, through a process called “deeming,” Health Canada may deem certain requirements as satisfied when conditions set out in the MRO are met. For instance, the review of the review of non-clinical, clinical, and chemistry and manufacturing information contained in a drug submission may qualify for this approach. The decision to deem is based on the fact that a comparable FRA has either given approval for the foreign drug or produced a document based on its review of a certain portion of the foreign drug submission.
To benefit from the framework, sponsors must request deeming when filing in Canada and demonstrate that the Canadian product is sufficiently comparable to the product reviewed by the FRA. Generally, the product must have the same medicinal ingredients, strength, dosage form, route of administration, and conditions of use. Any differences between the Canadian product and the foreign comparator must not negatively affect safety, efficacy, or quality.
The Three Reliance Pathways
The guidance establishes three distinct mechanisms through which reliance may occur.
1. General Deeming
General deeming applies when a foreign regulator has already authorized the product. Health Canada may then deem certain review requirements to have been satisfied based on the foreign decision or supporting review documents.
2. 120-Day Filing Pathway
Under this pathway, a sponsor files its Canadian submission within 120 days of filing the corresponding submission with an eligible foreign regulator. Unlike general deeming, the foreign authority has not yet reached a decision at the time of the Canadian filing. Following FRAs approval, Health Canada may then rely on the FRAs assessment to deem portions of the Canadian review requirements satisfied. This approach is designed to reduce the delay that often exists between major international filings and Canadian submissions.
3. Joint Review
Under a joint review, Health Canada reviews a drug submission along with 1 or more FRAs. Health Canada may rely on portions of the work conducted by the other regulators rather than duplicating those same assessments internally.
What Drugs Are Eligible?
Eligibility is determined by Health Canada's Incorporated by Reference (“IbR”) Lists, which identify both the drug classes that are eligible for reliance and the FRAs whose decisions or review documents may be relied on. There are two separate IbR Lists: one for human drugs and one for veterinary drugs. A submission can only benefit from the MRO if the relevant drug class, submission type, and reliance pathway are expressly identified in the applicable IbR List.
The lists are organized by submission type, which include New Drug Submissions (NDSs), Abbreviated New Drug Submissions (ANDSs), Supplements to New Drug Submissions (SNDSs), and Supplements to Abbreviated New Drug Submissions (SANDSs), and by the applicable reliance pathway (general deeming, 120-day filing, or joint review).
The lists may be amended without requiring amendments to the MRO itself. Health Canada has indicated that they are intended to evolve over time.
The Human Drugs IbR List
The initial human drugs IbR List focuses on a relatively small number of drugs.
Eligible products currently include certain pediatric medicines, treatments for tuberculosis, rare disease therapies, and other products intended to address unmet medical needs. Examples include pediatric formulations of anti-epileptic drugs, hydroxyurea products, albendazole products, glucarpidase and bile acid products.
The eligible FRAs vary depending on the drug category but generally include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Swissmedic, Australia's Therapeutic Goods Administration (TGA), and, in limited cases, Singapore's Health Sciences Authority (HSA).
The Veterinary Drugs IbR List
Unlike the human drugs list, which is restricted to selected therapeutic categories, the veterinary drugs list applies to many veterinary drugs. The eligible FRAs include the Australian Pesticides and Veterinary Medicines Authority (APVMA), the European Medicines Agency (EMA), the New Zealand Ministry for Primary Industries (NZMPI), the United Kingdom Veterinary Medicines Directorate (VMD), and the U.S. Food and Drug Administration (FDA).
What Does This Mean for Pharmaceutical Companies?
By allowing Health Canada to rely on certain foreign regulatory decisions and review documents, the framework may support earlier Canadian filings and encourage greater alignment between Canadian and global regulatory strategies.
In the short term, the most immediate impact is likely to be felt by innovative pharmaceutical companies, particularly those seeking to align Canadian filings more closely with global regulatory submissions. In particular, the 120-day filing pathway may incentivize sponsors to file in Canada much closer to other major international submissions, potentially reducing the delay between foreign and Canadian product launches.
For generic and biosimilar manufacturers, the immediate impact is expected to be limited. Health Canada has expressly stated that generics and biosimilars will be considered in a future phase of implementation, and the current Human Drugs IbR List does not provide broad reliance opportunities for these products. As a result, generic and biosimilar submissions will continue to proceed largely through existing regulatory pathways for the foreseeable future.
Nevertheless, future expansions of the IbR Lists could be significant. If additional drug classes and submission types are added, reliance pathways could eventually accelerate market access for generic and biosimilar products.
The current consultation therefore represents an important opportunity for stakeholders to provide input on the future evolution of the framework.
Conclusion
The MRO introduces a new reliance-based framework that enables Health Canada to leverage certain scientific assessments already conducted by trusted foreign regulators when reviewing eligible drug submissions.
This initiative aims to help Canadians get faster access to medicines. However, to truly improve access, it will need to be supported by other measures, as there are many barriers to access in Canada. For example, the impact of this initiative is significantly reduced by the combined effect of the PMPRB rules and the U.S. Most Favoured Nation (MFN) policy imposed on pharmaceutical companies.
Stakeholders have until September 12, 2026, to submit their comments to Health Canada.
