Health Canada Proposes Reliance on Foreign Drug Authority Decisions

Canada Health Canada Drug Announcements

Published February 5th, 2026

Detected March 13th, 2026

Summary

Health Canada is proposing a new Ministerial Reliance Order (MRO) that would allow the Minister to examine new drug submissions by relying on decisions from foreign regulatory authorities. This initiative is part of a broader Red Tape Review aimed at facilitating earlier drug availability in Canada while maintaining safety and quality standards. A 70-day consultation period is currently underway.

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What changed

Health Canada has initiated a 70-day public consultation on a proposed Ministerial Reliance Order (MRO) that would amend the Food and Drug Regulations. This MRO aims to allow the Minister to leverage decisions and documents from foreign regulatory authorities when reviewing new drug submissions. The initiative is intended to expedite drug availability in the Canadian market through more efficient reviews and enhanced international collaboration, without compromising product safety, effectiveness, or quality. Additional information for stakeholders is available, outlining Health Canada's interpretation of the proposed order's requirements.

Regulated entities, particularly drug manufacturers and pharmaceutical companies, should review the proposed MRO and accompanying materials. The consultation period ends on February 28, 2026, and feedback should be submitted by this date. While this document provides additional information, more detailed guidance will be issued upon publication of the final order in the Canada Gazette, Part II. Understanding this proposed shift in regulatory approach is crucial for future drug submission strategies in Canada.

What to do next

Review the proposed Ministerial Reliance Order (MRO) and accompanying 'Additional information for stakeholders' document.
Submit comments and feedback to Health Canada by the consultation deadline of February 28, 2026.
Prepare for potential changes to drug submission review processes based on reliance on foreign regulatory authority decisions.

Source document (simplified)

Additional information to accompany the proposed Order providing for reliance on decisions of, or documents produced by, foreign regulatory authorities in respect of certain drugs: Notice

Date issued: February 5, 2026

On December 20, 2025, Health Canada launched a 70-day consultation, (ending February 28, 2026) on the proposed Order providing for reliance on decisions of, or documents produced by, foreign regulatory authorities in respect of certain drugs. This proposed order is known as the Ministerial Reliance Order (MRO). It was pre-published in the Canada Gazette, Part I.

The MRO proposes amendments to the Food and Drug Regulations that would allow the Minister to examine new drug submissions using a reliance-based regulatory approach that leverages international collaboration.

As part of the Government of Canada's broader Red Tape Review commitment, the proposed MRO would help encourage earlier availability of drugs to the Canadian market. It would do this by:

facilitating more efficient reviews of drug submissions
enabling greater international collaboration, including joint reviews and reliance with regulatory partners This approach would be made while maintaining the safety, effectiveness and quality of these products.

Additional information

Health Canada has developed a document entitled Proposed Ministerial Reliance Order for Certain Drugs: Additional information for stakeholders. It provides additional information to support the consultation on the proposed MRO and its accompanying Regulatory Impact Analysis.

This document is not meant to provide guidance on the process for filing a drug submission under the Order. Instead, it outlines how Health Canada intends to interpret the requirements in the proposed Order. We will provide more detailed information in a guidance we will develop to support Canada Gazette, Part II publication.

Request this document

If you would like a copy of this document, email us at no-reply.pdd.publications.dmp.non-reponse@hc-sc.gc.ca. Include the following in the subject line: Request for additional information – Ministerial Reliance Order.