Routes of the same type are on the same row. Compare other markets.
13 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription application, non-prescription monograph and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. Canada: New drug submission (new active substance), 300 days. These are official targets, not actual review times.
| Pathway type | United States | Canada |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 |
| Full or mixed application, known active substance | New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Biosimilar new drug submissionNDS (biosimilar) · target 300 days |
| Non-prescription application | DIN application with supporting dataDINA / DINB · target 210 days · fee CA$319,282 |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | DIN application under a labelling standard or monographDINA / DINB (labelling standard) · target 60 days · fee CA$1,945 |
| Conditional or accelerated approval | Notice of compliance with conditionsNOC/c · target 200 days |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | Priority reviewtarget 183 days | Priority reviewPriority · target 180 days |
| Intensive development support designation | - |
| Rolling or phased review |
| Orphan or rare disease designation | - |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Special Access Program (drugs)SAP · relies on EU, US |
| Reliance route, abridged review | - | Ministerial reliance order (foreign decision deeming)SOR/2026-162 · relies on US, EU, CH, GB, AU |
| Work-sharing or joint review | - | Access Consortium work sharingNASWSI · target 300 days · relies on AU, SG, CH, GB Project Orbis (cancer drugs)Orbis · relies on US, AU, SG, BR, CH, GB |
| Device: exempt or self-declared |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | - |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | Medical device licence, Class IIIMDL Class III · target 60 days · fee CA$30,169 Medical device licence, Class IVMDL Class IV · target 75 days · fee CA$30,713 |
| Device: registration or licence with the regulator | - | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route |