Routes of the same type are on the same row. Compare other markets.
9 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, non-prescription application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
China: Marketing authorization for an innovative drug, 200 days. Australia: Registration of a new prescription medicine (standard pathway), 220 days. These are official targets, not actual review times.
| Pathway type | China | Australia |
|---|---|---|
| Full application, new active substance | Marketing authorization for an innovative drugChemical category 1; therapeutic biologic category 1 · target 200 days · fee CN¥593,900 Vaccine registrationPreventive biologic categories 1 to 3 · target 200 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 | Improved new drug (known active substance)Chemical category 2; therapeutic biologic category 2 · target 200 days |
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 chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP |
| Biosimilar application | - |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 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 |
| Priority or accelerated review | Priority review and approvaltarget 130 days | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 |
| Intensive development support designation | - |
| Orphan or rare disease designation | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Hong Kong and Macao drugs and devices in the Greater Bay Areatarget 5 days · relies on HK, MO | - |
| 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: premarket notification |
| Device: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | Class II device and IVD registrationtarget 60 days · fee CN¥210,900 Class III device and IVD registrationtarget 90 days · fee CN¥308,800 | - |
| 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 |