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.
United States: New drug application (full, new active ingredient), 304 days. United Kingdom: National assessment for innovative medicines, 150 days. These are official targets, not actual review times.
| Pathway type | United States | United Kingdom |
|---|---|---|
| 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 | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days |
| 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 |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | 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 | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Conditional or accelerated approval |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | Priority reviewtarget 183 days | - |
| Intensive development support designation |
| Rolling or phased review | Rolling reviewtarget 100 days |
| Orphan or rare disease designation | Orphan designationfee £124,194 |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 |
| 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: 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: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | - |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route |