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, conditional or accelerated approval, priority or accelerated review, device: premarket notification and more. The table lines up the routes of each type.
China: Marketing authorization for an innovative drug, 200 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | China | South Korea |
|---|---|---|
| Full application, new active substance | Marketing authorization for an innovative drugChemical category 1; therapeutic biologic category 1 · target 200 days · fee CN¥593,900 Vaccine registrationPreventive biologic categories 1 to 3 · target 200 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.
Improved new drug (known active substance)Chemical category 2; therapeutic biologic category 2 · target 200 days |
| Generic application | Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | - | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority review and approvaltarget 130 days | Priority review designation (GIFT)target 90 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Hong Kong and Macao drugs and devices in the Greater Bay Areatarget 5 days · relies on HK, MO | - |
| 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 | Class II device and IVD registrationtarget 60 days · fee CN¥210,900 Class III device and IVD registrationtarget 90 days · fee CN¥308,800 | - |
| Device: breakthrough or priority program |
| Other route |