Canada · Health Canada · New drugs
Review target
300 days
performance goal
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Canada works with Australia, Singapore, Switzerland and the United Kingdom to review the same new active substance file together. Each regulator reviews assigned modules, and each makes its own decision. Since July 2026, parts examined by a partner in a joint review can be deemed reviewed in Canada. New active substances or new indications filed at the same time in Canada and at least one other Access member.
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.
1. Expression of interest and filing in each country; 2. Work split between regulators; 3. Joint review (300 days); 4. Separate national decisions.
Yes. It relies on approvals from Australia, Switzerland, United Kingdom, Singapore (work sharing, work sharing, work sharing, work sharing).
Outcome: A separate Canadian notice of compliance.
Legal basis: Administrative work-sharing initiative; joint review deeming under section 4 of SOR/2026-162
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 300 days end to end with the official step targets. Targets, not actual times.
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. Joint reviews use the normal standards. | 300 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, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.