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, non-prescription monograph, conditional or accelerated approval and more. The table lines up the routes of each type.
South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | Brazil | South Korea |
|---|---|---|
| Full application, new active substance | Registration of a new medicinefee R$157,416 | 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 | Registration of an innovative medicinefee R$37,231 |
| Generic application | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Non-prescription application | - |
| Non-prescription monograph |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority review designation (GIFT)target 90 days |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 days |
| Early or compassionate access | - |
| Reliance route, abridged review | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP | - |
| Device: premarket notification | Notification of a class I or II medical devicetarget 30 days | 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 | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days | - |
| Device: breakthrough or priority program | - |
| Other route | Good manufacturing practice certification (CBPF)target 365 days |