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.
Italy: Centralised marketing authorisation, new active substance, 210 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 | Italy | Saudi Arabia |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | 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 | Centralised generic applicationtarget 210 days · fee €177,900 | Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application | Over-the-counter status and switch from prescriptiontarget 100 days |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 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 | Orphan designationtarget 90 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| 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 | Mutual recognition procedure with Italy as reference member statetarget 90 days · fee €16,309 Mutual recognition or decentralised procedure with Italy as concerned member statetarget 90 days · fee €81,546 Mutual recognition proceduretarget 90 days | Verification pathway (approved by both US FDA and EMA)target 30 days · relies on US, EU |
| Work-sharing or joint review | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days | - |
| Device: exempt or self-declared | - |
| 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 | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days | - |