Canada · Health Canada · New drugs
Review target
200 days
performance goal
Legal time limit
-
Not published
Steps
8
3 requirements
Application fee
-
A drug for a serious condition can be approved on promising evidence of effectiveness, with conditions such as confirmatory studies. The review target is 200 days. This policy is set to be replaced on April 1, 2027 by terms and conditions in the regulations. Serious, life-threatening or severely debilitating conditions with promising but not yet confirmed clinical benefit.
The official review target is 200 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Pre-submission meeting; 2. File the submission; 3. Screening (25 days); 4. Review (200 days); 5. Qualifying notice; 6. Response to qualifying notice; 7. Review of the response (30 days); 8. Notice of compliance with conditions.
Outcome: Notice of compliance with conditions, with a letter of undertaking.
Legal basis: Health Canada Notice of Compliance with Conditions policy and guidance (2016)
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 285 days end to end with the official step targets, of which up to 30 days are clock stops (time the applicant uses to answer). Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| 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. | 200 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, Priority review, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.