Routes of the same type are on the same row. Compare other markets.
9 pathway types exist in both markets: full application, new active substance, generic application, biosimilar application, non-prescription application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), 280 days. These are official targets, not actual review times.
| Pathway type | Brazil | Saudi Arabia |
|---|---|---|
| Full application, new active substance | Registration of a new medicinefee R$157,416 | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| Full or mixed application, known active substance | Registration of an innovative medicinefee R$37,231 |
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.
| - |
| Generic application | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 | Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application |
| Non-prescription application | Over-the-counter status and switch from prescriptiontarget 100 days |
| Non-prescription monograph | - |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority reviewtarget 168 days |
| Intensive development support designation | - | Breakthrough Medicine Programtarget 60 days Research and Investigational Drugs (RAID) designationtarget 40 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 days |
| 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 | Abridged pathway (approved by US FDA or EMA)target 60 days · relies on US, EU |
| Reliance route, recognition or verification | - | Verification pathway (approved by both US FDA and EMA)target 30 days · relies on US, EU |
| Device: premarket notification | Notification of a class I or II medical devicetarget 30 days | - |
| 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 | Medical Device Marketing Authorization (MDMA)MDMA · target 35 days · fee SAR 23,000 |
| Device: breakthrough or priority program | - |
| Other route | Good manufacturing practice certification (CBPF)target 365 days | - |