Canada · Health Canada · New drugs
Review target
300 days
performance goal
Legal time limit
-
Not published
Steps
12
13 requirements
Application fee
CA$616,593
From April 1, 2026
A new drug cannot be sold in Canada until the maker files a new drug submission and the agency issues a notice of compliance. The rules require the submission to let the agency judge the drug's safety and effectiveness. Biologics, vaccines and cell and gene therapies use the same route. Drugs with a medicinal ingredient never approved in Canada, including new biologics and vaccines.
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, new active substance is CA$616,593 for From April 1, 2026.
1. Pre-submission meeting; 2. File the new drug submission; 3. Administrative processing (10 days); 4. Screening 1 (45 days); 5. Review 1 (300 days); 6. Clarification requests; 7. Notice of deficiency response; 8. Decision; 9. Response to non-compliance; 10. Screening 2 (45 days); 11. Review 2 (150 days); 12. Market and post-market duties.
Outcome: Notice of compliance and a drug identification number (DIN). The notice can be held until patent and data protection rules are met.
Legal basis: Food and Drug Regulations, Part C, Division 8 (sections C.08.002 and C.08.004)
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 640 days end to end with the official step targets, of which up to 195 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 1 target in calendar days. | 45 days |
| Longest clock stopregulation. The regulations give 90 days to answer a notice, or a longer period the agency sets. | 90 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, new active substanceApplication · 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. A 25% credit applies if the agency misses its standard. | CA$616,593 |
Other routes in Canada: 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, Project Orbis (cancer drugs), Special Access Program (drugs), Drug and device combination products, Medical device licence, Class IV. 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 (33 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.