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, conditional or accelerated approval, priority or accelerated review, intensive development support designation and more. The table lines up the routes of each type.
China: Marketing authorization for an innovative drug, 200 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | China | Taiwan |
|---|---|---|
| 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 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 |
Improved new drug (known active substance)Chemical category 2; therapeutic biologic category 2 · target 200 days |
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 chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | - | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days | - |
| 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 and approvaltarget 130 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 |
| 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 |
| 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 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 | - | Class 3 device licensetarget 200 days · fee NT$100,000 |
| 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 | 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 |