Canada · Health Canada · New drugs
Review target
300 days
performance goal
Legal time limit
-
Not published
Steps
5
9 requirements
Application fee
CA$319,282
From April 1, 2026
A drug with a known ingredient is still a new drug if its combination, use, dose or route is new in Canada. It is filed as a new drug submission. Significant changes to an approved new drug, such as a new indication, need a supplement and a new notice of compliance. New combinations, new indications, new dosage forms or routes, and other significant changes to approved new drugs.
The official review target is 300 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The review fee, clinical or non-clinical data plus chemistry and manufacturing data is CA$319,282 for From April 1, 2026.
1. File the submission or supplement; 2. Screening (45 days); 3. Review 1 (300 days); 4. Deficiency response; 5. Decision.
Outcome: Notice of compliance for the new drug or for the supplement.
Legal basis: Food and Drug Regulations, sections C.08.001, C.08.002 and C.08.003
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 435 days end to end with the official step targets, of which up to 90 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
| Validationperformance goal. Screening target in calendar days. | 45 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. | 300 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Review fee, clinical or non-clinical data plus chemistry and manufacturing dataApplication · From April 1, 2026 · Small businesses (fewer than 100 employees, or gross revenue of $30,000 to under $5 million, counting affiliates) can get 50% off. A small business filing its first drug submission can get the full fee waived. | CA$319,282 |
| Review fee, clinical or non-clinical data onlySupplement · From April 1, 2026 · Small businesses (fewer than 100 employees, or gross revenue of $30,000 to under $5 million, counting affiliates) can get 50% off. A small business filing its first drug submission can get the full fee waived. | CA$127,668 |
| Review fee, chemistry and manufacturing data onlySupplement · From April 1, 2026 · Small businesses (fewer than 100 employees, or gross revenue of $30,000 to under $5 million, counting affiliates) can get 50% off. A small business filing its first drug submission can get the full fee waived. | CA$44,269 |
Other routes in Canada: New drug submission (new active 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, Project Orbis (cancer drugs), Special Access Program (drugs), Drug and device combination products. See all routes on the Canada page or explore them in the Regulatory section.
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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.