Routes of the same type are on the same row. Compare other markets.
13 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, conditional or accelerated approval and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. Netherlands: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | United States | Netherlands |
|---|---|---|
| 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 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 |
| 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 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 | National generic or hybrid applicationfee €37,290 Centralised generic applicationtarget 210 days · fee €177,900 |
| 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 | - | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Traditional or herbal registration | - | Traditional herbal medicine registrationfee €5,670 |
| 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 | Supply on physician statement (named patient)Gmw Art. 40(3)(c) |
| Reliance route, recognition or verification | - | Mutual recognition and repeat use: Dutch steps and feesNL/H/xxxx/xxx/MR · fee €31,990 Licence for public health reasons (product marketed elsewhere in the EU)Gmw Art. 52 · relies on EU Mutual recognition proceduretarget 90 days |
| Work-sharing or joint review | - | Decentralised procedure: Dutch steps and feesNL/H/xxxx/xx/DC · fee €102,640 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: registration or licence with the regulator | - |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route | Informed consent applicationArt. 10c Directive 2001/83/EC · fee €9,380 Duplex marketing authorisationfee €9,380 Homeopathic medicine registrationfee €3,890 Parallel import licenceRVG2//RVG1 · fee €2,600 Temporary import exemption during shortagesRegeling Gmw Art. 3.17a · relies on EU, GB Hospital exemption for advanced therapy medicinesGmw Art. 40(3)(d) Integral drug-device combination authorised as a medicinetarget 210 days |