Canada · Health Canada · New drugs
Review target
180 days
performance goal
Legal time limit
-
Not published
Steps
6
3 requirements
Application fee
-
Priority review gives eligible new drug submissions and supplements a shorter review target of 180 calendar days instead of 300. It is for drugs for serious conditions with substantial evidence of a major benefit. Drugs for serious, life-threatening or severely debilitating conditions with no marketed treatment in Canada, or a clearly better benefit and risk balance.
The official review target is 180 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Request priority status; 2. Decision on the request (30 days); 3. File the submission; 4. Screening (25 days); 5. Priority review (180 days); 6. Decision.
Outcome: The submission is reviewed against the 180-day target. The decision itself is a normal notice of compliance.
Legal basis: Health Canada Priority Review of Drug Submissions policy and guidance (no separate regulation)
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 295 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
| Validationperformance goal. Screening target in calendar days. | 25 days |
| Review targetperformance goal. Official target in calendar days for the agency's work. It is not an actual review time. Time the applicant takes to answer questions is not counted. | 180 days |
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, 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, 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.