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, 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.
United States: New drug application (full, new active ingredient), 304 days. Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), 280 days. These are official targets, not actual review times.
| Pathway type | United States | Saudi Arabia |
|---|---|---|
| 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 | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| Full or mixed application, known active substance | New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 | - |
| Generic application |
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.
Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 |
Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 |
| Non-prescription application | Over-the-counter status and switch from prescriptiontarget 100 days |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority reviewtarget 183 days | 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 |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | - |
| Reliance route, abridged review | - | 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: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | - |
| 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 | - | Medical Device Marketing Authorization (MDMA)MDMA · target 35 days · fee SAR 23,000 |
| Device: breakthrough or priority program |
| Device: humanitarian or limited population route | - |
| Other route | - |