Routes of the same type are on the same row. Compare other markets.
14 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. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | United States | Taiwan |
|---|---|---|
| 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 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 |
| 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 |
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 | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | - |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 |
| 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 reviewtarget 183 days | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | Breakthrough therapy designationtarget 240 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| 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: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | Class 1 device listingfee NT$10,000 |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | 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 | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | Class 3 device licensetarget 200 days · fee NT$100,000 |
| 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 | - |
| Device: humanitarian or limited population route | - |
| Other route |