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.
India: Permission to import or manufacture a new drug with a new molecule, 90 days. Singapore: New drug application for a registered active ingredient (NDA-2), 180 days. These are official targets, not actual review times.
| Pathway type | India | Singapore |
|---|---|---|
| Full application, new active substance | Permission to import or manufacture a new drug with a new moleculeForm CT-18 / CT-21 · target 90 days · fee ₹500,000 Vaccine approval and lot releasetarget 90 days Cell and gene therapy productstarget 90 days | 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.
Permission for new claims of an approved new drugForm CT-18 / CT-21, Table 3 · target 90 days Permission for a fixed dose combinationForm CT-18 / CT-21 · target 90 days · fee ₹500,000 |
New drug application for a registered active ingredient (NDA-2)NDA-2 / NDA-3 · target 180 days |
| Generic application | Permission for a new drug already approved in India (subsequent applicant)Form CT-18 / CT-21, Table 2 · target 90 days · fee ₹200,000 State manufacturing licence for drugs that are not new drugsForm 24 / Form 25 · fee ₹6,000 | 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 | Similar biologic (biosimilar) approvaltarget 90 days | 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 |
| Conditional or accelerated approval | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days | - |
| Priority or accelerated review | Expedited reviewSecond Schedule para 1(2)(ii)(B) | Priority Review Scheme for devicesfee SGD 17,500 |
| Orphan or rare disease designation | Orphan drug provisionsRule 2(1)(x) · target 90 days | - |
| Early or compassionate access | Import of an unapproved new drug by a government hospitalForm CT-24 / CT-25 · fee ₹10,000 Manufacture of an unapproved new drug under trial for individual patientsForm CT-26 / CT-27 · fee ₹5,000 | Special access for an unregistered medicine (named patient)Special Access Route (Named-Patient) · target 14 days |
| Reliance route, abridged review | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU | 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: premarket notification |
| Device: premarket approval by the regulator | Permission for a medical device without a predicateForm MD-26 / MD-27 · fee ₹100,000 · relies on GB, US, AU, CA, JP, EU Permission for a new in vitro diagnostic deviceForm MD-28 / MD-29 · fee ₹25,000 | - |
| Device: conformity assessment by a certification body | Manufacturing licence for Class A and B devicesForm MD-3 / MD-5 | - |
| Device: registration or licence with the regulator | Import licence for medical devices and IVDsForm MD-14 / MD-15 · relies on AU, CA, JP, EU, US, GB Manufacturing licence for Class C and D devicesForm MD-7 / MD-9 · target 45 days | 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 certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 | Class 1 cell or tissue product notificationtarget 14 days · fee SGD 95 |