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, intensive development support designation and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 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 Kingdom | Saudi Arabia |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| Full or mixed application, known active substance | National assessment for established medicinestarget 210 days · fee £34,335 | - |
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 |
Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 |
Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application | 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 | Over-the-counter status and switch from prescriptiontarget 100 days |
| Conditional or accelerated approval |
| Approval under exceptional circumstances | - |
| 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 | Rolling reviewtarget 100 days |
| Orphan or rare disease designation | Orphan designationfee £124,194 |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | - |
| Reliance route, abridged review | - | Abridged pathway (approved by US FDA or EMA)target 60 days · relies on US, EU |
| 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 | Verification pathway (approved by both US FDA and EMA)target 30 days · relies on US, EU |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | - |
| Device: conformity assessment by a certification body | - |
| 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 | - |
| Other route | - |