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.