Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription application, 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. Singapore: New drug application for a registered active ingredient (NDA-2), 180 days. These are official targets, not actual review times.
| Pathway type | Australia | Singapore |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | 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 |
| 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 | 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) |
| Biosimilar application | Biosimilar applicationNDA-2 / NDA-3 (biosimilar) · target 180 days · fee SGD 17,100 · relies on EU, US, CA, GB, CH, AU |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 | 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 |
| 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 Review Scheme for devicesfee SGD 17,500 |
| Orphan or rare disease designation | - |
| Early or compassionate access | - | Special access for an unregistered medicine (named patient)Special Access Route (Named-Patient) · target 14 days |
| 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 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 |
| 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 | 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 | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US | 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 |
| Device: conformity assessment by a certification body | - |
| 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 |
| 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 | Class 1 cell or tissue product notificationtarget 14 days · fee SGD 95 |