Routes of the same type are on the same row. Compare other markets.
8 pathway types exist in both markets: full application, new active substance, generic application, non-prescription application, conditional or accelerated approval, priority or accelerated review, intensive development support designation and more. The table lines up the routes of each type.
China: Marketing authorization for an innovative drug, 200 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 | China | Saudi Arabia |
|---|---|---|
| Full application, new active substance | Marketing authorization for an innovative drugChemical category 1; therapeutic biologic category 1 · target 200 days · fee CN¥593,900 Vaccine registrationPreventive biologic categories 1 to 3 · target 200 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 | Improved new drug (known active substance)Chemical category 2; therapeutic biologic category 2 · target 200 days | - |
| 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.
Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP |
Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| Biosimilar application | - |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days | Over-the-counter status and switch from prescriptiontarget 100 days |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority review and approvaltarget 130 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 | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Hong Kong and Macao drugs and devices in the Greater Bay Areatarget 5 days · relies on HK, MO | - |
| 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 | - |
| Device: registration or licence with the regulator | Class II device and IVD registrationtarget 60 days · fee CN¥210,900 Class III device and IVD registrationtarget 90 days · fee CN¥308,800 | Medical Device Marketing Authorization (MDMA)MDMA · target 35 days · fee SAR 23,000 |
| Device: breakthrough or priority program |
| Other route | - |