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, biosimilar application, conditional or accelerated approval, intensive development support designation and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Taiwan |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 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 |
National assessment for established medicinestarget 210 days · fee £34,335 |
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 medicine applicationRegulation 51B · target 210 days · fee £12,589 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Biosimilar registrationfee NT$1,500,000 |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | - |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 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 |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | - | 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 | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 |
| Reliance route, abridged review | - | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| Reliance route, recognition or verification | International Recognition Procedure, Recognition Atarget 60 days · fee £24,688 · relies on US, EU, JP, CA, AU, CH, SG International Recognition Procedure, Recognition Btarget 110 days · fee £83,580 · relies on US, EU, JP, CA, AU, CH, SG CE marked devices in Great Britainrelies on EU | - |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | - |
| 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: conformity assessment by a certification body | - |
| 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 |
| Other route |