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, priority or accelerated review, early or compassionate access and more. The table lines up the routes of each type.
Singapore: New drug application for a registered active ingredient (NDA-2), 180 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Singapore | Taiwan |
|---|---|---|
| Full application, new active substance | New drug application, full evaluationNDA-1, NDA-2, NDA-3 (full route) · target 270 days · fee SGD 83,100 Class 2 cell, tissue or gene therapy product, full evaluationNDA-1, NDA-2, NDA-3 (CTGTP full route) · target 270 days · fee SGD 82,900 | 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 |
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.
| Full or mixed application, known active substance | New drug application for a registered active ingredient (NDA-2)NDA-2 / NDA-3 · target 180 days | 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 application, abridged evaluationGDA-1, GDA-2 (abridged route) · target 240 days · fee SGD 4,280 Generic drug application, verification evaluationGDA-1, GDA-2 (verification route) · target 120 days · fee SGD 10,600 · relies on US, EU, CA, GB, CH, AU Generic drug application, verification-CECA evaluationGDA verification-CECA · target 90 days · fee SGD 10,600 · relies on US, EU, CA, GB, CH, AU Standard essential medicine applicationGDA (standard essential medicine) | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar applicationNDA-2 / NDA-3 (biosimilar) · target 180 days · fee SGD 17,100 · relies on EU, US, CA, GB, CH, AU | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | Non-prescription medicine application (abridged)NDA (abridged), Appendix 6 · target 180 days · fee SGD 11,600 · relies on AU, CA, US, GB Reclassification of a registered medicine (switch)MAV-2 · target 180 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 Review Scheme for devicesfee SGD 17,500 | 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 | Special access for an unregistered medicine (named patient)Special Access Route (Named-Patient) · target 14 days |
| Reliance route, abridged review | New drug application, abridged evaluationNDA-1, NDA-2, NDA-3 (abridged route) · target 180 days · fee SGD 11,600 New drug application, verification evaluationNDA-1, NDA-2, NDA-3 (verification route) · target 60 days · fee SGD 17,100 · relies on US, EU, CA, GB, CH, AU Class 2 cell, tissue or gene therapy product, abridged evaluationNDA-1, NDA-2, NDA-3 (CTGTP abridged route) · target 180 days · fee SGD 13,900 · relies on AU, CA, US, EU, GB Class B device registration, abridged evaluationAbridged evaluation route · target 100 days · fee SGD 2,010 · relies on AU, CA, EU, JP, US, MY Class C device registration, abridged evaluationAbridged evaluation route · target 160 days · fee SGD 3,900 · relies on AU, CA, EU, JP, US, MY Class C device registration, expedited evaluationExpedited Class C Registration (ECR-1, ECR-2) · target 120 days · fee SGD 3,340 · relies on AU, CA, EU, JP, US Class D device registration, abridged evaluationAbridged evaluation route · target 220 days · fee SGD 6,250 · relies on AU, CA, EU, JP, US, MY Class D device registration, expedited evaluationExpedited Class D Registration (EDR) · target 180 days · fee SGD 5,930 · relies on AU, CA, EU, JP, US | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| Reliance route, recognition or verification | Class B device immediate registrationImmediate Class B Registration (IBR) · target 0 days · fee SGD 1,000 · relies on AU, CA, EU, JP, US Class C immediate registration for standalone mobile appsImmediate Class C Registration (ICR) · target 0 days · fee SGD 3,340 · relies on AU, CA, EU, JP, US | - |
| Work-sharing or joint review | Project Orbis (cancer medicines)relies on US Access Consortium work sharingrelies on AU, CA, CH, GB Singapore-Malaysia generic work-sharing pilotrelies on MY | - |
| 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 | Class B device registration, full evaluationFull evaluation route · target 160 days · fee SGD 3,900 Class C device registration, full evaluationFull evaluation route · target 220 days · fee SGD 6,250 Class D device registration, full evaluationFull evaluation route · target 310 days · fee SGD 12,000 Device with a registrable medicine (Class D)fee SGD 75,600 | 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 |
| Other route | Class 1 cell or tissue product notificationtarget 14 days · fee SGD 95 |