Routes of the same type are on the same row. Compare other markets.
11 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 Kingdom: National assessment for innovative medicines, 150 days. Australia: Registration of a new prescription medicine (standard pathway), 220 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Australia |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 |
| Full or mixed application, known active substance | National assessment for established medicinestarget 210 days · fee £34,335 |
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 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | - |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 days | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | - | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 |
| Intensive development support designation | - |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | - |
| 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 | 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 | 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 | Project Orbis (cancer medicines)target 150 days · relies on US | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US |
| 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 |