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.
Italy: Centralised marketing authorisation, new active substance, 210 days. Australia: Registration of a new prescription medicine (standard pathway), 220 days. These are official targets, not actual review times.
| Pathway type | Italy | Australia |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 |
| 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.
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 |
| 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 |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 |
| Intensive development support designation | - |
| 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 | - |
| 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 | Mutual recognition procedure with Italy as reference member statetarget 90 days · fee €16,309 Mutual recognition or decentralised procedure with Italy as concerned member statetarget 90 days · fee €81,546 Mutual recognition proceduretarget 90 days | Register inclusion of medical devices and IVDs using manufacturer evidencefee A$1,603 · relies on EU, US, CA, JP, SG, GB |
| Work-sharing or joint review | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US |
| 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 | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 |