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, non-prescription application, priority or accelerated review and more. The table lines up the routes of each type.
Germany: Centralised marketing authorisation, new active substance, 210 days. Singapore: New drug application for a registered active ingredient (NDA-2), 180 days. These are official targets, not actual review times.
| Pathway type | Germany | Singapore |
|---|---|---|
| Full application, new active substance | National marketing authorisation (new active substance)§ 21 AMG · fee €52,500 Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 National authorisation of vaccines, sera, blood products and allergens (Paul-Ehrlich-Institut)§§ 21, 25 Abs. 8, 77 Abs. 2 AMG · fee €2,000 | New drug application, full evaluationNDA-1, NDA-2, NDA-3 (full route) · target 270 days · fee SGD 83,100 |
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 | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 | New drug application for a registered active ingredient (NDA-2)NDA-2 / NDA-3 · target 180 days |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 National generic authorisation§ 24b AMG · fee €16,000 | 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 | Centralised biosimilar applicationtarget 210 days · fee €732,400 | Biosimilar applicationNDA-2 / NDA-3 (biosimilar) · target 180 days · fee SGD 17,100 · relies on EU, US, CA, GB, CH, AU |
| Well-established use | National authorisation based on literature (well-established use)§ 22 Abs. 3 AMG · fee €22,100 Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application | Prescription status and switch to non-prescription§ 48 AMG; AMVV | 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 | Standard licence (monograph route)§ 36 AMG; StandZV | - |
| Traditional or herbal registration | Traditional herbal medicine registration§§ 39a to 39d AMG · fee €15,600 | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | - |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Priority Review Scheme for devicesfee SGD 17,500 |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | - |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| Early or compassionate access | Compassionate use programme§ 21 Abs. 2 Nr. 3 AMG; AMHV | 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 |
| Reliance route, recognition or verification | Mutual recognition procedure (Germany as reference or concerned member state)§ 25b Abs. 2 AMG · fee €48,600 · relies on EU Mutual recognition proceduretarget 90 days | 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 | Decentralised procedure with Germany as reference member state§ 25b Abs. 3 AMG · fee €92,800 Decentralised proceduretarget 210 days | 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: 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 |
| Other route | Homeopathic medicine registration§§ 38, 39 AMG · fee €6,400 Official batch release by the Paul-Ehrlich-Institut§ 32 AMG · relies on EU Hospital exemption for advanced therapy medicines§ 4b AMG · fee €4,250 Approval of tissue preparations§ 21a AMG · fee €2,000 Special national authorisation for a device without CE marking§ 7 MPDG · fee €250 DiGA fast track: listing of digital health applications for reimbursement§ 139e SGB V; DiGAV · target 91 days · fee €3,000 Listing of digital care applications (DiPA)§ 78a SGB XI; DiPAV · target 91 days · fee €3,000 Integral drug-device combination authorised as a medicinetarget 210 days | Class 1 cell or tissue product notificationtarget 14 days · fee SGD 95 |