Routes of the same type are on the same row. Compare other markets.
10 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, priority or accelerated review and more. The table lines up the routes of each type.
Spain: Centralised marketing authorisation, new active substance, 210 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | Spain | South Korea |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | New drug item permittarget 70 days · fee ₩410,000,000 Item permit for biological products and vaccinestarget 115 days · fee ₩8,031,000 |
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.
| Full or mixed application, known active substance | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application | - |
| Non-prescription monograph | - |
| Traditional or herbal registration | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Priority review designation (GIFT)target 90 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| Early or compassionate access | - |
| Reliance route, recognition or verification | Mutual recognition procedure involving Spaintarget 90 days · relies on EU Mutual recognition proceduretarget 90 days | - |
| Work-sharing or joint review | Decentralized procedure with Spain as reference member statetarget 120 days · fee €17,073 Decentralised proceduretarget 210 days | - |
| 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 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 | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days |