Routes of the same type are on the same row. Compare other markets.
12 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, non-prescription monograph and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. These are official targets, not actual review times.
| Pathway type | United States | Brazil |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | 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.
Registration of an innovative medicinefee R$37,231 |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 |
| Non-prescription application |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority reviewtarget 183 days |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 days |
| Pediatric plan or incentive | - |
| 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 |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | Notification of a class I or II medical devicetarget 30 days |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | - |
| 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 |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route | Good manufacturing practice certification (CBPF)target 365 days |