Health Canada introduces new efforts to expedite review of drug submissions

An Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order) has been proposed under the Food and Drugs Act. Health Canada has recognized that stakeholders have raised concerns about delays in bringing products to market in Canada. The proposed legislation aims to help reduce Health Canada’s regulatory review times for new drugs and improve access to drugs for Canadian patients by enabling reliance on decisions or documents produced by certain foreign regulatory authorities (FRAs).

What you need to know

• The Order is not yet law. It would come into force after publication in the Canada Gazette, Part II.
• The Order would allow the Minister of Health to deem that the examination of certain chemistry and manufacturing, non-clinical, and/or clinical information has taken place for Canadian purposes, on the basis of a decision or documents produced by an FRA, without Health Canada undertaking its own substantive review of the same underlying information.
  • Canada’s Minister of Health currently has the ability to consider information obtained through FRAs in the context of Health Canada’s review of drug submissions, at its discretion. The Order would introduce a more formal and better-defined mechanism for manufacturers to request the Minister’s reliance on such FRAs.
• Eligibility for this proposed process will be limited to those specific classes of drugs and specific FRAs in the List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents, which will be incorporated by reference into the Order. We are awaiting further details on classes of drugs and FRAs to be included in this proposed list.
• Interested parties may submit their comments on the Order to Health Canada until February 28, 2026.

The scope of the proposed order

On December 20, 2025, the Order was proposed under the Food and Drugs Act. The proposed legislation aims to help reduce Health Canada’s regulatory review times for new drugs and improve access for Canadian patients by enabling reliance on drug reviews of certain foreign regulatory authorities (FRAs).

The Order will introduce three scenarios, pursuant to which the Minister of Health can deem parts of their examination of drug submissions to have been completed, based on an FRA’s decision or documents: 1) general deeming; 2) 120-day filing; and 3) joint reviews. In each scenario, if the submission meets the requirements under the Order, the requirement for the Minister to examine such parts of the regulatory submission under the Food and Drug Regulations is deemed to have taken place on the basis of the decision or documents produced by the FRA, without Health Canada conducting an independent review.

Different types of submissions (e.g., new drug submissions, abbreviated new drug submissions) will be eligible for deeming under different scenarios. Extraordinary use new drug submissions, or drugs related to emergency/alternate pathways (such as special access program and public health emergency drugs), will not be eligible for review under the Order.

General deeming

General deeming will be used for drugs for which a decision to authorize marketing of the drug has already been made by an FRA. Manufacturers can request deeming of the safety and effectiveness of a new drug based on 1) chemistry and manufacturing; 2) non-clinical information; and/or 3) clinical information accepted by an FRA.

120-day filing

The 120-day filing scenario will encompass drug submissions for which a decision to authorize has not yet been made by an FRA, and where a submission has been filed in Canada within 120 days of being filed with the FRA. This is intended to encourage earlier filing of submissions for innovator drugs in Canada, for use by manufacturers who want to leverage an anticipated positive FRA decision. This should also accelerate Health Canada’s review because they can begin reviewing other components in parallel to the FRA’s review of the components to be deemed. In this scenario, the safety and effectiveness of the new drug is deemed based on all of the components of 1) chemistry and manufacturing; 2) non-clinical information; and 3) clinical information that were submitted to the FRA. If the FRA authorizes the drug in the foreign jurisdiction, the manufacturer would provide additional documents to Health Canada, such as the marketing authorization from the FRA and any approved labels, as well as information on any changes made to the drug and its labelling in the course of the FRA’s review which result in differences between the Canadian drug under review and the foreign drug.

More information on the process and timing of review is expected to be published by Health Canada to support the implementation of the Order.

Joint reviews

Health Canada may collaborate with an FRA to conduct a joint review of drug submissions, where one health agency takes the lead in reviewing the drug submission. Where Health Canada participates in a joint review, a portion of Health Canada’s examination of the submission can be deemed complete on the basis of documents prepared by the FRA leading the review.

The Order aims to allow Health Canada to more fully leverage an FRA’s review while minimizing the impact on how joint reviews are currently conducted by Health Canada.

Eligibility and requirements

The Order will only apply where the drug submission is for a class of drug and for review by an FRA that is listed in the List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents (IbR List). The drug should also have the same medicinal ingredient, strength, dosage form and route of administration as the drug reviewed by the FRA.

While a draft of the IbR List has not been published, the Regulatory Impact Assessment Statement published for the Order states that the list will start with a limited class of drugs and FRAs, with the intent to expand in the future. The Minister’s considerations when generating the IbR List will include 1) similarities between the FRA’s review standards and requirements and Health Canada’s own; 2) the FRA’s history of collaboration with Health Canada; and 3) public interest (e.g., where there is an unmet need, or a similar drug is not available in Canada). We anticipate the eligible FRAs will include the European Medicines Agency and the U.S. Food and Drug Administration.

When requesting review under the Order, manufacturers must continue to submit their drug submission in accordance with the requirements of the Food and Drug Regulations, in addition to providing the information required to demonstrate that the drug submission meets the requirements for deeming under the Order.

Certain differences between the drug that is the subject of the Canadian submission and the drug reviewed by the FRA may be permissible under this new framework, including different packaging or colourants; however, the manufacturer must describe any such differences and demonstrate that these differences would not impact the safety and effectiveness of the drug to be marketed in Canada. If the differences could potentially impact the safety and effectiveness of the drug, deeming would not be used for that component of the submission.

Consultation period

Stakeholders are welcome to provide their feedback on the proposed Order until February 28, 2026. Health Canada has developed a guide to provide stakeholders with additional information to support the consultation, the Proposed Ministerial Reliance Order for Certain Drugs: Additional information for stakeholders, which can be obtained via request.