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, well-established use, non-prescription application and more. The table lines up the routes of each type.
European Union: Centralised marketing authorisation, new active substance, 210 days. United Kingdom: National assessment for innovative medicines, 150 days. These are official targets, not actual review times.
| Pathway type | European Union | United Kingdom |
|---|---|---|
| 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 | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days |
| 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 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 | Biosimilar applicationRegulation 53B · target 150 days |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 |
| 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 designationtarget 90 days | Orphan designationfee £124,194 |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| Early or compassionate access | - | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 |
| Reliance route, recognition or verification | Mutual recognition proceduretarget 90 days | 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 | Decentralised proceduretarget 210 days | Project Orbis (cancer medicines)target 150 days · relies on US |
| Device: exempt or self-declared | - |
| Device: conformity assessment by a certification body |
| Device: registration or licence with the regulator | - |
| Other route | Integral drug-device combination authorised as a medicinetarget 210 days |