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, full or mixed application, known active substance, generic application, biosimilar 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. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Australia | Taiwan |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | 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.
New drug registration, known ingredient (new combination, route, dosage form, dose or strength)target 300 days · fee NT$500,000 New indication or new dosage changetarget 180 days |
| Generic application | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Priority or accelerated review | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | - | Breakthrough therapy designationtarget 240 days |
| Orphan or rare disease designation | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Early or compassionate access | - |
| 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 | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| 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 | - |
| 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 | 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: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | - | 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 | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 |