Health Canada has proposed a framework under which manufacturers can ask it to rely on foreign regulatory decisions to speed up the review of new drug submissions. The framework, which would apply to new drugs in certain classes, is intended to make the review process more efficient and make new drugs available earlier in Canada. It appears that Health Canada intends to introduce reliance on foreign regulatory decisions gradually, beginning with veterinary and other lower-risk products. Health Canada is accepting feedback on the framework until February 28, 2026.

Background

  • A new drug submission requires extensive information about the drug product’s safety, efficacy, and quality. This information must be reviewed and found to be complete by the regulator, Health Canada, before the product can be authorized for sale in Canada.
  • On December 20, 2025, Health Canada issued a draft Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (Order). The draft Order sets out a framework for relying on foreign regulatory decisions when reviewing certain new drug submissions.

Scope of draft Order

The draft Order would permit a manufacturer to ask Health Canada to “deem” the examination of large sections of its new drug submission—chemistry and manufacturing (C&M), non‑clinical, and/or clinical information—to be complete based on a decision from a foreign regulatory authority (FRA) about the corresponding foreign drug. Health Canada would not engage in a substantive review of the information deemed complete, potentially speeding up the approval process.

Under the draft Order, the manufacturer could only ask Health Canada to rely on a FRA decision if the new drug falls within a class of drugs set out in a List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents (IbR List). The IbR list would also identify which FRAs could be relied upon for each drug class. The draft Order does not confirm which FRAs will be included in the IbR List; however, the List would be expected to include jurisdictions with whom Health Canada already routinely collaborates (e.g., the European Union).

Health Canada’s commentary (RIAS) on the draft Order suggests that it will introduce the draft Order slowly by limiting the initial IbR List to low-risk drugs. For instance, the commentary states that the examples of classes of new drugs that could be added to the IbR List include veterinary drugs and drugs where “a child-friendly format is not authorized in Canada that include pediatric conditions of use”. However, the commentary adds: “Over time, changes to the IbR List may occur as the Department continues to assess the classes of drugs and FRAs that could be included”.

Three scenarios for relying on a foreign decision

The Order sets out three scenarios in which a manufacturer can ask Health Canada to expedite review of its new drug submission based on a FRA decision about a corresponding foreign drug (where the drug class and the FRA are on the IbR List):

  • General Deeming: Where the decision has already been made by the FRA, the manufacturer can request that Health Canada deem complete the C&M, non‑clinical, and/or clinical review.
  • 120‑day Filing: Where the submission is filed with Health Canada within 120 days of a corresponding foreign submission, the manufacturer can request that Health Canada deem complete the C&M, non‑clinical, and clinical review based on the FRA decision when it issues.
  • Joint Reviews: Where Health Canada participates in a joint review with a FRA, the Order would allow for deemed completion of parts of the drug submission based on the FRA’s review report.

The types of new drug submissions (e.g., NDS, SNDS, ANDS) that can be considered under each scenario are different, but this issue is still being explored by Health Canada.

Key requirements to rely on a foreign decision

Across all three scenarios, in addition to the IbR List requirements, the manufacturer’s Canadian drug submission must:

  • Be a full submission in accordance with existing requirements;
  • Have the same medicinal ingredient(s), strength, dosage form, and route of administration as the foreign drug; and
  • Have conditions of use that fall within those of the foreign drug.

The Order would still allow for deemed completion where there are certain differences between the drug filed in Canada and the authorized foreign drug (e.g., different packaging), provided that the manufacturer describes all differences and demonstrates that they will not affect the drug’s safety or efficacy.

Certain information specific to Canada could not be deemed completed and so would always be examined by Health Canada (e.g., product monograph, brand name).

Consultation and coming into force

Health Canada is seeking feedback on the proposed Order until February 28, 2026. Once finalized, the Order would come into force upon publication in the Canada Gazette, Part II. Following publication of the Order, Health Canada intends to publish guidance to support the Order’s implementation.

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