Routes of the same type are on the same row. Compare other markets.
8 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, conditional or accelerated approval, orphan or rare disease designation and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | South Korea |
|---|---|---|
| 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 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.
National assessment for established medicinestarget 210 days · fee £34,335 |
| Generic application | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| 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 | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | - | Priority review designation (GIFT)target 90 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 | - |
| 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 | - |
| 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 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 | - |
| Device: breakthrough or priority program | - |
| Other route |