Routes of the same type are on the same row. Compare other markets.
9 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription monograph, conditional or accelerated approval and more. The table lines up the routes of each type.
Canada: New drug submission (new active substance), 300 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | Canada | South Korea |
|---|---|---|
| Full application, new active substance | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 | New drug item permittarget 70 days · fee ₩410,000,000 Item permit for biological products and vaccinestarget 115 days · fee ₩8,031,000 Item permit for advanced biological products (cell and gene therapy)target 70 days · fee ₩205,000,000 |
| Full or mixed application, known active substance |
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 submission (generic)ANDS · target 180 days · fee CA$71,953 | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | Biosimilar new drug submissionNDS (biosimilar) · target 300 days | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Non-prescription application | 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 | Priority review designation (GIFT)target 90 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | - |
| 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 | - | Class 1 medical device notificationtarget 5 days In vitro diagnostic device notification (Class 1)target 5 days · fee ₩85,000 Digital medical device notification (Class 1)target 5 days |
| 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 | Medical device permit (Classes 2 to 4)target 80 days · fee ₩98,430,000 In vitro diagnostic device permit (Classes 2 to 4)target 80 days · fee ₩1,495,000 Digital medical device permit or certification (including software)target 80 days · fee ₩1,495,000 |
| Device: conformity assessment by a certification body | - | Class 2 medical device certificationtarget 5 days · fee ₩130,000 In vitro diagnostic device certification (Class 2)target 5 days · fee ₩130,000 |
| 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 | - |
| Other route |