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, full or mixed application, known active substance, generic application, biosimilar application, non-prescription application, reliance route, abridged review and more. The table lines up the routes of each type.
Singapore: New drug application for a registered active ingredient (NDA-2), 180 days. These are official targets, not actual review times.
| Pathway type | Mexico | Singapore |
|---|---|---|
| Full application, new active substance | Registration of a medicine with a new moleculeCOFEPRIS-04-030 · fee MX$198,496 Registration of an innovative biotechnology medicineCOFEPRIS-04-030 | 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.
New drug application for a registered active ingredient (NDA-2)NDA-2 / NDA-3 · target 180 days |
| Generic application | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 | 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 | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 | Biosimilar applicationNDA-2 / NDA-3 (biosimilar) · target 180 days · fee SGD 17,100 · relies on EU, US, CA, GB, CH, AU |
| 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 |
| Traditional or herbal registration | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 | - |
| Priority or accelerated review | - | Priority Review Scheme for devicesfee SGD 17,500 |
| Early or compassionate access | - | Special access for an unregistered medicine (named patient)Special Access Route (Named-Patient) · target 14 days |
| Reliance route, abridged review | Abbreviated reliance route for medicinesCOFEPRIS-04-040 · relies on US, EU, JP, CA, CH, WHO, BR Abbreviated reliance route for medical devicesCOFEPRIS-04-050 · relies on AU, BR, CA, CN, EU, JP, RU, SG, KR, CH, GB, US | 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 | - | 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: exempt or self-declared | - |
| Device: premarket notification | - |
| Device: registration or licence with the regulator | Registration of a Class I medical deviceCOFEPRIS-04-060 · fee MX$16,499 Registration of a Class II medical deviceCOFEPRIS-04-060 · fee MX$24,198 Registration of a Class III medical deviceCOFEPRIS-04-060 · fee MX$30,798 Simplified registration of listed low-risk devicesCOFEPRIS-04-070 | 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 |
| Other route | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 | Class 1 cell or tissue product notificationtarget 14 days · fee SGD 95 |