Canada · Health Canada · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
For drugs for a condition on the official list of public health threats, a new drug submission can be filed before all data are ready, with a plan for the missing parts. Approval rests on benefits outweighing risks given the public health need. Drugs and vaccines for a condition listed as a threat to public health in Canada.
1. File with a plan for missing data; 2. Rolling delivery of missing data; 3. Review; 4. Decision.
Outcome: Notice of compliance, possibly with terms and conditions on the DIN.
Legal basis: Food and Drug Regulations, sections C.08.001.1 and C.08.002(2.1) to (2.5), as amended by SOR/2024-238
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, Extraordinary use new drug submission, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.