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.
Australia: Registration of a new prescription medicine (standard pathway), 220 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 | Australia | Saudi Arabia |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| Full or mixed application, known active substance | - | |
| 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.
Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 | Over-the-counter status and switch from prescriptiontarget 100 days |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Priority or accelerated review | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 | 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 | Comparable overseas regulator report-based process, approach ACOR-A · relies on US, EU, GB, CA, CH, JP, SG Comparable overseas regulator report-based process, approach BCOR-B · relies on US, EU, GB, CA, CH, JP, SG | Abridged pathway (approved by US FDA or EMA)target 60 days · relies on US, EU |
| Reliance route, recognition or verification | Register inclusion of medical devices and IVDs using manufacturer evidencefee A$1,603 · relies on EU, US, CA, JP, SG, GB | Verification pathway (approved by both US FDA and EMA)target 30 days · relies on US, EU |
| Work-sharing or joint review | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US | - |
| Device: premarket notification | - |
| 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 | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 | - |