Routes of the same type are on the same row. Compare other markets.
11 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. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | South Korea | Taiwan |
|---|---|---|
| Full application, new active substance | 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 | New drug registration, new active substancetarget 360 days · fee NT$1,500,000 Biological product registration (recombinant products, vaccines, plasma products, allergens)target 360 days · fee NT$1,500,000 |
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 | New drug registration, known ingredient (new combination, route, dosage form, dose or strength)target 300 days · fee NT$500,000 New indication or new dosage changetarget 180 days |
| Generic application | Generic drug item permit (bioequivalence)target 55 days | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar item permittarget 115 days · fee ₩310,000,000 | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription monograph |
| Conditional or accelerated approval | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Priority or accelerated review | Priority review designation (GIFT)target 90 days | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | - | Breakthrough therapy designationtarget 240 days |
| Orphan or rare disease designation | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Early or compassionate access | - |
| Reliance route, abridged review | - | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| 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 | Class 1 device listingfee NT$10,000 |
| Device: new low or moderate risk device | - | License for a device with no similar product in Taiwantarget 220 days · fee NT$130,000 License for a world-first devicetarget 365 days · fee NT$250,000 |
| 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 | Class 3 device licensetarget 200 days · fee NT$100,000 |
| 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 1 device licensetarget 80 days · fee NT$15,000 Class 2 device licensetarget 140 days · fee NT$58,000 · relies on US, EU In vitro diagnostic device license (Class 2 and Class 3)target 150 days · fee NT$100,000 |
| Device: breakthrough or priority program | - |
| Other route |