Routes of the same type are on the same row. Compare other markets.
12 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, priority or accelerated review and more. The table lines up the routes of each type.
Spain: Centralised marketing authorisation, new active substance, 210 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Spain | Taiwan |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | 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 | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 | 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 | Centralised generic applicationtarget 210 days · fee €177,900 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 | Biosimilar registrationfee NT$1,500,000 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application | - |
| Non-prescription monograph | - |
| Traditional or herbal registration | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 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 | Orphan designationtarget 90 days | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 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 |
| Reliance route, recognition or verification | Mutual recognition procedure involving Spaintarget 90 days · relies on EU Mutual recognition proceduretarget 90 days | - |
| Work-sharing or joint review | Decentralized procedure with Spain as reference member statetarget 120 days · fee €17,073 Decentralised proceduretarget 210 days | - |
| Device: exempt or self-declared | - |
| 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 | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days |