Canada · Health Canada · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Canada joins the US FDA and other partners to review promising cancer drugs at the same time. Canadian review standards do not change, but some decisions can come sooner. Each regulator decides on its own. Cancer drugs selected by the FDA for concurrent review, filed in Canada under an expedited route.
1. FDA selects the file; 2. File in Canada; 3. Concurrent review; 4. Canadian decision.
Yes. It relies on approvals from Australia, Brazil, Switzerland, United Kingdom, Singapore, United States (work sharing, work sharing, work sharing, work sharing, work sharing, work sharing).
Outcome: A separate Canadian notice of compliance.
Legal basis: Administrative collaboration led by the US FDA; normal Canadian submission rules apply
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 30 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), Ministerial reliance order (foreign decision deeming), Access Consortium work sharing, 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.