Health Canada is asking the public to comment on a new plan that would let the agency rely more on decisions made by trusted foreign drug regulators. The proposal outlines how Canada would roll out this system in stages and which types of drugs and foreign agencies would be included first.
Currently, Health Canada, the Canadian federal agency that develops and enforces federal health regulations and standards, uses its existing authority under the Food and Drugs Act and Food and Drug Regulations to consider information or other material obtained from other regulatory authorities in its examination of new drug submissions.
The proposal, published May 5, 2026, focuses on creating an “incorporated‑by‑reference” list. This list would name the drug categories and foreign regulatory authorities – such as the US Food and Drug Administration (FDA) or the European Commission – whose decisions Canada could use when reviewing drug applications.
Health Canada plans to publish the official order in summer 2026. Once active, the Ministerial Reliance Order – officially named “Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs” – would allow the Minister of Health to treat certain information in a drug application as already reviewed if a trusted foreign regulator has made a decision on the same drug.
The order covers three situations:
- when a foreign regulator has already approved the drug;
- when a company files in Canada within 120 days of filing with a foreign regulator; and
- when Canada and another regulator review a drug together.
This new system would not replace Canada’s drug approval process. Instead, it is meant to speed up reviews and help bring drugs to the Canadian market sooner.
Incorporated‑by‑reference list
The list that supports this system will be organized into sections based on the three review scenarios and joint reviews. Before adding any drug class or foreign regulator to the list, Health Canada will evaluate whether the addition is safe, in the public interest, and unlikely to create new risks.
The agency also will consider how changes might affect Canadian drug manufacturers. As such, foreign regulators will only be added if their standards and review practices are similar to Canada’s and if Health Canada already has a formal working relationship with them.
Health Canada plans to build the list in phases. The first phase will focus on a small number of human drug categories, especially those where treatment gaps exist, such as drugs for children. More drug classes would be added in later phases.
For joint reviews, Health Canada plans to begin immediately with partners in the Access Consortium, which includes regulators in Singapore, Australia, Switzerland, and the United Kingdom.
The regulator will continue to review labels and, for food‑animal drugs, withdrawal periods before meat or milk can enter the food supply.
Context
The Canadian government is reviewing its federal rules to cut red tape and speed up regulatory decisions through the Red Tape Reduction Act. As part of this effort, Health Canada is looking at ways to align more closely with trusted foreign regulators like the FDA to help bring medicine to the Canadian market faster.
The Red Tape Review, launched in July 2025, aims to eliminate outdated rules and reduce unnecessary regulatory burden. One major focus is improving international alignment, since differing rules between countries can slow down product approvals and create trade barriers.
Health Canada says relying on decisions from comparable foreign regulators can help streamline reviews, reduce delays, and support faster access to new drugs.
Around the world, regulators are increasingly working together and sharing scientific expertise to speed up approvals and reduce duplication.
This approach, according to Health Canada, allows it to focus its resources where they are most needed while still protecting public health. The proposed Ministerial Reliance Order is part of this broader effort. It would allow Health Canada to use certain decisions or documents from foreign regulators when reviewing drug applications.
The goal of the order to make reviews more efficient, reduce filing delays, expand international collaboration, and help new medicines reach Canadians sooner – without changing Canada’s safety, quality, or effectiveness standards.
The notice for public comment marks the start of a 30‑day period.