Routes of the same type are on the same row. Compare other markets.
12 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.
Australia: Registration of a new prescription medicine (standard pathway), 220 days. Netherlands: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Australia | Netherlands |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | 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.
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 | Centralised generic applicationtarget 210 days · fee €177,900 National generic or hybrid applicationfee €37,290 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | - | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 |
| Traditional or herbal registration | - | Traditional herbal medicine registrationfee €5,670 |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | - | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 | Accelerated assessmenttarget 150 days |
| 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 | - | Supply on physician statement (named patient)Gmw Art. 40(3)(c) |
| Reliance route, abridged review | Comparable overseas regulator report-based process, approach ACOR-A · relies on US, EU, GB, CA, CH, JP, SG Comparable overseas regulator report-based process, approach BCOR-B · relies on US, EU, GB, CA, CH, JP, SG | - |
| Reliance route, recognition or verification | Register inclusion of medical devices and IVDs using manufacturer evidencefee A$1,603 · relies on EU, US, CA, JP, SG, GB | 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 | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US | 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 | - |
| Device: conformity assessment by a certification body |
| Device: registration or licence with the regulator | - |
| Device: breakthrough or priority program | - |
| Other route | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 | 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 |