Routes of the same type are on the same row. Compare other markets.
12 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, conditional or accelerated approval and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. Canada: New drug submission (new active substance), 300 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Canada |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 |
| Full or mixed application, known active substance | National assessment for established medicinestarget 210 days · fee £34,335 |
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 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Biosimilar new drug submissionNDS (biosimilar) · target 300 days |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | - |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 days | DIN application with supporting dataDINA / DINB · target 210 days · fee CA$319,282 |
| Non-prescription monograph | - | 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 reviewPriority · target 180 days |
| Intensive development support designation | - |
| Rolling or phased review | Rolling reviewtarget 100 days |
| Orphan or rare disease designation | Orphan designationfee £124,194 | - |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | 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 |
| Reliance route, recognition or verification | International Recognition Procedure, Recognition Atarget 60 days · fee £24,688 · relies on US, EU, JP, CA, AU, CH, SG International Recognition Procedure, Recognition Btarget 110 days · fee £83,580 · relies on US, EU, JP, CA, AU, CH, SG CE marked devices in Great Britainrelies on EU | - |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | 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 approval by the regulator | - | 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: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 |
| Other route |