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 States: New drug application (full, new active ingredient), 304 days. Australia: Registration of a new prescription medicine (standard pathway), 220 days. These are official targets, not actual review times.
| Pathway type | United States | Australia |
|---|---|---|
| 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 | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 |
| 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 |
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 | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Priority or accelerated review | Priority reviewtarget 183 days | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation |
| Pediatric plan or incentive | - |
| 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 | - | 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 | - | 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 | 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 | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 |