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, non-prescription application, conditional or accelerated approval and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Brazil |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | Registration of a new medicinefee R$157,416 |
| 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 |
Registration of an innovative medicinefee R$37,231 |
| Generic application | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days |
| 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 |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | - |
| Intensive development support designation | - |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | Special procedure for new medicines for rare diseasestarget 60 days |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 |
| Reliance route, abridged review | - | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, 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 | - | Notification of a class I or II medical devicetarget 30 days |
| Device: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days |
| Other route | Good manufacturing practice certification (CBPF)target 365 days |