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Ministerial Reliance Order permitting Health Canada to rely on decisions of foreign regulators now in force

Authored byBrandon Heard

On July 15, 2026, the Minister of Health’s Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs ("Reliance Order”) was published in Part II of the Canada Gazette and came into force. This is part of Health Canada’s Red Tape Review, including its ongoing efforts to improve access to drugs.

Health Canada simultaneously published the initial “List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents” (Incorporated by Reference List, or “IbR List”) for human drugs and veterinary drugs, and opened a consultation on a related draft guidance.

The Ministerial Reliance Order & draft guidance

As previously reported, the Reliance Order will allow Health Canada to rely on decisions and documents issued by trusted foreign regulatory authorities (“FRAs”) to “deem” complete part of Health Canada’s review of a drug submission. Certain clinical, non-clinical or chemistry and manufacturing information may be eligible for deeming.  

Deeming is available in the following three scenarios for drug submissions that meet the requirements of the Order:

  1. General deeming (Division 1 of the IbR List): An FRA has already made a decision about a foreign drug.
  2. 120-Day filing (Division 2 of the IbR List): A manufacturer files a submission with Health Canada within 120 days of filing with an FRA, whose decision is pending. Deeming may occur when the requirements of the Order are met, i.e., when the FRA grants marketing authorization for the foreign drug.
  3. Joint review (Division 3 of the IbR List): Health Canada reviews the Canadian drug submission in partnership with one or more FRAs.

It is intended that general deeming based on an already authorized foreign drug be available for new drug submissions (or "NDSs”, Part 1 of the IbR List), abbreviated NDSs (“ANDSs”, Part 2 of the IbR List) and supplemental NDSs and ANDSs (“SNDSs” and “SANDSs”, Part 3 of the IbR List). Currently, no drug classes or FRAs are identified in Part 2 (ANDS) of the initial IbR List. The other two categories of deeming are intended to be available for NDSs and SNDSs but exclude submissions for subsequent-entry drugs filed on the basis of a direct or indirect comparison to another drug authorized for sale in Canada (for example, biosimilars and generics).

In all instances, certain conditions must be met for deeming to apply under the Order:

  • the proposed Canadian drug falls within a class of drugs listed in the applicable part of the IbR List;
  • the manufacturer demonstrates that the drug has been authorized by an eligible FRA corresponding to that class on the IbR List;
  • the proposed Canadian drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug;
  • the conditions of use for the proposed Canadian drug fall within those authorized by the FRA for the foreign drug;
  • there are no differences between the proposed Canadian drug and the foreign drug related to the parts of the submission for which deeming is being sought that would negatively affect the drug's safety or efficacy;
  • the authorization granted by the FRA for the foreign drug was not reliant on a decision by another foreign regulator, unless it involved a joint review between the FRA and the other foreign regulator on the applicable part of the IbR List; and
  • a prior submission or supplement filed by the manufacturer for the proposed Canadian drug has not previously been withdrawn or cancelled after receiving a notice of deficiency or non-compliance or refusal from Health Canada.

The draft guidance describes the evidentiary and filing requirements that must be met by a manufacturer in each deeming scenario. Among other things, the manufacturer must state which deeming option it is seeking and (i) for general deeming, identify what sets of information it is seeking to have deemed; (ii) for 120-day filing, state that it seeks to have all clinical, non-clinical and chemistry and manufacturing information deemed; and (iii) for joint reviews, confirm which FRAs will participate, submit (among other things) an evaluation plan and state what sets of information examined by an FRA it is seeking to have deemed. Additional relevant information will be provided or referred to in the “Sponsor’s Request and Attestation Form for Human Drugs” or “Reliance Attestation Form” submitted with the drug submission.  

Incorporated by Reference (IbR) List

The Reliance Order applies to specified classes of drugs and corresponding FRAs identified in the IbR List for human drugs and veterinary drugs. Each IbR List has three Parts: Part 1: NDSs, Part 2: ANDSs and Part 3: SNDSs and SANDSs. Parts 1 and 3 are further divided into the divisions described above for general deeming (Division 1), 120-day filing (Division 2) and joint review (Division 3).

Notable features of the current IbR List are summarized below. To be eligible under the Reliance Order, the drug at issue must meet all the requirements for the submission type, drug class, qualifier and FRA listed in the IbR List.

Human drugs:

  • General deeming (Division 1): 
    • NDSs (Part 1) for a small number of primarily pediatric-focused drug classes (using the ATC classification system) are eligible (that is, the drug submission must include an indication for pediatric populations). Health Canada published additional guidance on the interpretation of the IbR List for pediatric-focused drugs. 
    • SNDSs (Part 3) for all 14 first-level ATC drug classes (subject to a couple of exclusions, including vaccines) are eligible where the supplement includes an indication for pediatric populations.
    • Eligible FRAs depend on the class of the drug and any applicable qualifier but are generally the regulatory authorities of Europe, Switzerland, the U.K. and the U.S. (and Australia in the case of albendazole and drugs for the treatment of tuberculosis).
  • Joint review (Division 3):
    • NDSs (Part 1) and SNDSs (Part 3) for all 14 first-level ATC drug classes, without any qualifiers, are eligible for joint review. 
    • Eligible FRAs are limited to the regulatory authorities of Australia, Singapore, Switzerland and the U.K.
  • Not currently included in IbR List:
    • NDSs and SNDSs for biosimilar drugs for general deeming (Division 1).
    • ANDSs (Part 2) and supplements thereto (Part 3).
    • NDSs or SNDSs for 120-day filing deeming (Division 2).

Veterinary drugs: 

NDSs and ANDSs, as well as supplements thereto, for all drug classes are eligible for general deeming (Division 1) or 120-day filing (Division 2). Joint reviews (Division 3) have not been implemented and remain available through existing pathways. Eligible FRAs include the regulatory authorities of Australia, Europe, New Zealand, the U.K. and the U.S. for all drug classes except antiparasitic drugs, for which only the U.S. FDA is an eligible FRA.

Future updates to the IbR List: Typical updates will follow a 75-day consultation process and a 6-month delay to implementation. Timeframes may be shortened to address serious and immediate risks to health and safety. The draft guidance describes the following preconditions for the decision to add/remove classes of drugs or FRAs, among other factors that may be considered:

  • New drug classes: Health Canada will add drug classes to the IbR List only if: (i) a particular drug class is necessary for public health or is otherwise in the public interest and (ii) the drugs in the class do not introduce unacceptable risks or uncertainties to health, safety or, where applicable, the environment.  
  • New FRAs: Health Canada may add a new FRA to the IbR List after assessing whether its regulatory practices are comparable to its own.

IP protections

The Reliance Order does not impact data protection under section C.08.004.1 of the Food and Drug Regulations, protections under the Patented Medicines (Notice of Compliance Regulations) or the Certificate of Supplementary Protection regime.

Health Canada’s consultation on the draft guidance is open for feedback until September 12, 2026. See also Health Canada’s webpage: The Ministerial Reliance Order: About the Order.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group. 

The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.