Routes of the same type are on the same row. Compare other markets.
7 pathway types exist in both markets: full application, new active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review, orphan or rare disease designation and more. The table lines up the routes of each type.
South Korea: New drug item permit, 70 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 | South Korea | Saudi Arabia |
|---|---|---|
| Full application, new active substance | New drug item permittarget 70 days · fee ₩410,000,000 Item permit for biological products and vaccinestarget 115 days · fee ₩8,031,000 Item permit for advanced biological products (cell and gene therapy)target 70 days · fee ₩205,000,000 | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| 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.
| - |
| Generic application | Generic drug item permit (bioequivalence)target 55 days | Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| 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 review designation (GIFT)target 90 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 |
| 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: premarket notification | Class 1 medical device notificationtarget 5 days In vitro diagnostic device notification (Class 1)target 5 days · fee ₩85,000 Digital medical device notification (Class 1)target 5 days | - |
| Device: premarket approval by the regulator | Medical device permit (Classes 2 to 4)target 80 days · fee ₩98,430,000 In vitro diagnostic device permit (Classes 2 to 4)target 80 days · fee ₩1,495,000 Digital medical device permit or certification (including software)target 80 days · fee ₩1,495,000 | - |
| Device: conformity assessment by a certification body | Class 2 medical device certificationtarget 5 days · fee ₩130,000 In vitro diagnostic device certification (Class 2)target 5 days · fee ₩130,000 | - |
| 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 | - |