Canada · Health Canada · Generics
Review target
180 days
performance goal
Legal time limit
-
Not published
Steps
5
10 requirements
Application fee
CA$71,953
From April 1, 2026
A generic copy of an approved new drug is filed as an abbreviated new drug submission. The rules require it to be the pharmaceutical equivalent of, and bioequivalent with, a Canadian reference product, with the same route and conditions of use. Generic versions of drugs that have a Canadian reference product.
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.
The review fee, comparative studies (with or without chemistry and manufacturing data) is CA$71,953 for From April 1, 2026.
1. File the abbreviated submission; 2. Screening (45 days); 3. Review 1 (180 days); 4. Deficiency response; 5. Decision.
Outcome: Notice of compliance that names the Canadian reference product and serves as a declaration of equivalence.
Legal basis: Food and Drug Regulations, section C.08.002.1
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 315 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
| 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. Generic files fall under the comparative studies class. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Review fee, comparative studies (with or without chemistry and manufacturing data)Application · 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$71,953 |
Other routes in Canada: New drug submission (new active substance), New drug submission or supplement (known substance), 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.