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 monograph, conditional or accelerated approval and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | United States | South Korea |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | 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.
New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Non-prescription application | - |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority reviewtarget 183 days | Priority review designation (GIFT)target 90 days |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | - |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | 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: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | 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: breakthrough or priority program |
| Device: humanitarian or limited population route | - |
| Other route |