Routes of the same type are on the same row. Compare other markets.
14 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, non-prescription monograph and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. Germany: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | United States | Germany |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 National marketing authorisation (new active substance)§ 21 AMG · fee €52,500 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 | New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 | 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 | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Centralised generic applicationtarget 210 days · fee €177,900 National generic authorisation§ 24b AMG · fee €16,000 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| 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 monograph | Over-the-counter monograph orderOMOR · fee $614,608 | 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 | Priority reviewtarget 183 days | Accelerated assessmenttarget 150 days |
| Intensive development support designation |
| Rolling or phased review | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Compassionate use programme§ 21 Abs. 2 Nr. 3 AMG; AMHV |
| 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 |
| Work-sharing or joint review | - | 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: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | - |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | - |
| Device: conformity assessment by a certification body | - |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| 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 |