Routes of the same type are on the same row. Compare other markets.
16 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.
United Kingdom: National assessment for innovative medicines, 150 days. Italy: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Italy |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 |
| 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.
National assessment for established medicinestarget 210 days · fee £34,335 |
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 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Centralised generic applicationtarget 210 days · fee €177,900 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 days |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | - | Accelerated assessmenttarget 150 days |
| Intensive development support designation |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | Orphan designationtarget 90 days |
| Pediatric plan or incentive | - | Paediatric investigation plantarget 60 days |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 |
| 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 | 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 |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days |
| Device: exempt or self-declared | - |
| 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 |