Routes of the same type are on the same row. Compare other markets.
15 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, well-established use, non-prescription application and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. Germany: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Germany |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | 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 |
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 | National assessment for established medicinestarget 210 days · fee £34,335 | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Centralised generic applicationtarget 210 days · fee €177,900 National generic authorisation§ 24b AMG · fee €16,000 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | 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 | Reclassification to pharmacy or general saletarget 120 days | Prescription status and switch to non-prescription§ 48 AMG; AMVV |
| 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 |
| Intensive development support designation |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | Orphan designationtarget 90 days |
| Pediatric plan or incentive | - | Paediatric investigation plantarget 60 days |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | Compassionate use programme§ 21 Abs. 2 Nr. 3 AMG; AMHV |
| Reliance route, recognition or verification | International Recognition Procedure, Recognition Atarget 60 days · fee £24,688 · relies on US, EU, JP, CA, AU, CH, SG International Recognition Procedure, Recognition Btarget 110 days · fee £83,580 · relies on US, EU, JP, CA, AU, CH, SG CE marked devices in Great Britainrelies on EU | 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 |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | Decentralised procedure with Germany as reference member state§ 25b Abs. 3 AMG · fee €92,800 Decentralised proceduretarget 210 days |
| Device: exempt or self-declared | - |
| Device: conformity assessment by a certification body |
| Device: registration or licence with the regulator | - |
| 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 |