Routes of the same type are on the same row. Compare other markets.
11 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.
Italy: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Italy | Brazil |
|---|---|---|
| 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 | Registration of a new medicinefee R$157,416 |
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 | Registration of an innovative medicinefee R$37,231 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application |
| Non-prescription monograph | - |
| 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 | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | Special procedure for new medicines for rare diseasestarget 60 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access |
| 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 | 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 | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days | - |
| Device: exempt or self-declared | - |
| 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 | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days | Good manufacturing practice certification (CBPF)target 365 days |