Routes of the same type are on the same row. Compare other markets.
19 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, well-established use, non-prescription application and more. The table lines up the routes of each type.
Italy: Centralised marketing authorisation, new active substance, 210 days. Spain: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Italy | Spain |
|---|---|---|
| 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 | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 |
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 | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Centralised generic applicationtarget 210 days · fee €177,900 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application |
| Traditional or herbal registration | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Accelerated assessmenttarget 150 days |
| Intensive development support designation |
| Orphan or rare disease designation | Orphan designationtarget 90 days | Orphan designationtarget 90 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | Paediatric investigation plantarget 60 days |
| Emergency or temporary authorisation | - |
| Early or compassionate access |
| Reliance route, recognition or verification | Mutual recognition procedure with Italy as reference member statetarget 90 days · fee €16,309 Mutual recognition or decentralised procedure with Italy as concerned member statetarget 90 days · fee €81,546 Mutual recognition proceduretarget 90 days | Mutual recognition procedure involving Spaintarget 90 days · relies on EU Mutual recognition proceduretarget 90 days |
| Work-sharing or joint review | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days | 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 | - |
| Device: conformity assessment by a certification body |
| Device: registration or licence with the regulator |
| Other route | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days |