Canada · Health Canada · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
6 requirements
Application fee
-
Drugs to treat or prevent the effects of chemical, biological, radiological or nuclear exposure can be approved mainly on animal and other non-human evidence, because human efficacy trials are not possible. There is no fee. Medical countermeasures where exposing human volunteers would be unethical and exposures are rare.
1. File the extraordinary use submission; 2. Review; 3. Decision.
Outcome: Notice of compliance. Sales are limited to governments.
Legal basis: Food and Drug Regulations, sections C.08.002.01, C.08.002.02 and C.08.004.01
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).
Official step durations
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, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.