Canada · Health Canada · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
6 requirements
Application fee
-
Since July 15, 2026, the agency can treat its review of parts of a new drug submission (quality, non-clinical or clinical) as done, based on an approval by a listed foreign regulator. It applies only to drug classes on an official list, which starts with mainly pediatric uses. New drug submissions or supplements for drugs in a listed class that a listed foreign regulator has already approved.
1. Foreign approval by a listed regulator; 2. Optional 120-day filing; 3. File the submission and ask for deeming; 4. Review of non-deemed parts; 5. Decision.
Yes. It relies on approvals from Australia, Switzerland, European Union, United Kingdom, United States (shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: Notice of compliance after a shortened examination of the deemed parts.
Legal basis: Food and Drugs Act, section 30.06; Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (SOR/2026-162)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 120 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Canada: New drug submission (new active substance), New drug submission or supplement (known substance), Abbreviated new drug submission (generic), Biosimilar new drug submission, DIN application with supporting data, Priority review, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Access Consortium work sharing, Project Orbis (cancer drugs), Special Access Program (drugs), Drug and device combination products. See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.