New draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities: Notice

July 15, 2026
Our file number: 26-104176-25

On this page

• New review approach for human and veterinary drugs
• Phased implementation approach
• Seeking your feedback on draft guidance
• Contact us

New review approach for human and veterinary drugs

The Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs took effect on July 15, 2026. This Ministerial Reliance Order is part of the Government of Canada’s commitment to reduce red tape.

Learn more:

• Red Tape Review
• Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

The Order introduces new regulations that are meant to:

• improve efficiency
• reduce duplication in the review process
• promote greater international collaboration
• encourage new human and veterinary drug submissions in Canada

The Order allows:

• the Minister to rely on decisions or documents from foreign regulatory authorities (FRAs) when reviewing submissions for specific drug classes and
• deeming (or accepting) the requirement to examine sets of information and material in certain drug submissions filed under Part C, Division 8 of the Food and Drug Regulations to be met based on decisions or documents made by FRAs

The Order includes a list that’s incorporated by reference. This IbR list sets out the classes of drugs and the FRAs for which deeming can apply.

For reliance to be used, manufacturers must request deeming when filing a drug submission in Canada. They must demonstrate that:

• the drug related to their submission has been authorized by an FRA on the IbR list for the class of drugs listed and
• any differences in the drug that they are seeking to have deemed compared to the drug authorized by the FRA does not negatively impact its safety or effectiveness

There are 3 scenarios for deeming:

1. General deeming: drug submissions for which a decision has already been made by an FRA about a foreign drug
2. 120-day filing: drug submissions for which a decision by an FRA to authorize a foreign drug has not yet been made and are filed in Canada within 120 days of the FRA filing
3. Joint reviews: drug submissions subject to joint review by both Health Canada and 1 or more FRAs

Learn more:

• Notice on the proposed phased implementation of the incorporated by reference list for the Ministerial Reliance Order
• List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs
• List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Veterinary drugs

The following types of human and veterinary drug submissions are eligible for deeming:

• new drug submissions (NDSs)
• abbreviated NDS (ANDSs)
• supplements to NDS (SNDSs)
• supplements to ANDS (SANDSs)

The following types of submissions are not eligible:

• extraordinary use new drug submissions (EUNDSs) or their supplements
• abbreviated extraordinary use new drug submissions (AEUNDSs) or their supplements
• submissions for public health emergency drugs
• submissions for drugs outside the scope of the IbR list

Phased implementation approach

The Ministerial Reliance Order is one further example of the collaborations that Health Canada engages in with foreign regulators. We regularly take part in joint reviews, share scientific assessments and have mutual recognition arrangements.

Examples of these international collaborations include:

• Project Orbis, for cancer treatments
• Access Consortium, for health products
• International collaboration for veterinary drugs

This experience is beneficial for implementing the Order.

As we and industry gain experience, we will learn how to use the Order most effectively. For this reason, we’re using a phased implementation approach for the classes of drugs and FRAs that can be eligible to use reliance for human drugs. Generics and biosimilars will be considered in a future phase.

All parts of the IbR list have been implemented for veterinary drugs. Of the 3 scenarios, the joint review scenario is excluded as there are already international initiatives in place for veterinary drugs.

The lessons we learn from implementing the Order will help us make changes to the IbR list in the future.

Learn more:

• About the Ministerial Reliance Order

Seeking your feedback on draft guidance

We’re consulting with manufacturers and other interested parties for 60 days on the draft guidance. Feedback from the consultation will be used to inform the revisions to the draft guidance and refine our processes.

Learn about the draft guidance and how you can take part in the consultation:

• Consultation on draft guidance on Ministerial reliance order for certain human and veterinary drugs
• Draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities

Contact us

If you have any questions or comments about this notice, email the Bureau of Policy, Science and International Programs, Pharmaceutical Drugs Directorate, at policy_bureau_enquiries@hc-sc.gc.ca.