Routes of the same type are on the same row. Compare other markets.
9 pathway types exist in both markets: full application, new active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review, intensive development support designation and more. The table lines up the routes of each type.
Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), 280 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Saudi Arabia | Taiwan |
|---|---|---|
| Full application, new active substance | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 | New drug registration, new active substancetarget 360 days · fee NT$1,500,000 Biological product registration (recombinant products, vaccines, plasma products, allergens)target 360 days · fee NT$1,500,000 |
| 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 | Registration of a generic medicinetarget 155 days · fee SAR 40,000 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | Over-the-counter status and switch from prescriptiontarget 100 days | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Priority or accelerated review | Priority reviewtarget 168 days | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | Breakthrough Medicine Programtarget 60 days Research and Investigational Drugs (RAID) designationtarget 40 days | Breakthrough therapy designationtarget 240 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Early or compassionate access | - |
| Reliance route, abridged review | Abridged pathway (approved by US FDA or EMA)target 60 days · relies on US, EU | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| 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 device listingfee NT$10,000 |
| Device: new low or moderate risk device | - | License for a device with no similar product in Taiwantarget 220 days · fee NT$130,000 License for a world-first devicetarget 365 days · fee NT$250,000 |
| Device: premarket approval by the regulator | - | Class 3 device licensetarget 200 days · fee NT$100,000 |
| Device: registration or licence with the regulator | Medical Device Marketing Authorization (MDMA)MDMA · target 35 days · fee SAR 23,000 | Class 1 device licensetarget 80 days · fee NT$15,000 Class 2 device licensetarget 140 days · fee NT$58,000 · relies on US, EU In vitro diagnostic device license (Class 2 and Class 3)target 150 days · fee NT$100,000 |
| Device: breakthrough or priority program | - |
| Other route | - |