Routes of the same type are on the same row. Compare other markets.
10 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.
Canada: New drug submission (new active substance), 300 days. Australia: Registration of a new prescription medicine (standard pathway), 220 days. These are official targets, not actual review times.
| Pathway type | Canada | Australia |
|---|---|---|
| Full application, new active substance | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 | 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 submission or supplement (known substance)NDS / SNDS · target 300 days · fee CA$319,282 | |
| Generic application |
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.
Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 |
| Biosimilar application | Biosimilar new drug submissionNDS (biosimilar) · target 300 days |
| Non-prescription application | DIN application with supporting dataDINA / DINB · target 210 days · fee CA$319,282 | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 |
| Non-prescription monograph | DIN application under a labelling standard or monographDINA / DINB (labelling standard) · target 60 days · fee CA$1,945 | - |
| Conditional or accelerated approval | Notice of compliance with conditionsNOC/c · target 200 days | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | Priority reviewPriority · target 180 days | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 |
| Rolling or phased review | - |
| Orphan or rare disease designation | - |
| Early or compassionate access | Special Access Program (drugs)SAP · relies on EU, US | - |
| Reliance route, abridged review | Ministerial reliance order (foreign decision deeming)SOR/2026-162 · relies on US, EU, CH, GB, AU | 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 · target 300 days · relies on AU, SG, CH, GB Project Orbis (cancer drugs)Orbis · relies on US, AU, SG, BR, CH, GB | 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: premarket approval by the regulator | Medical device licence, Class IIIMDL Class III · target 60 days · fee CA$30,169 Medical device licence, Class IVMDL Class IV · target 75 days · fee CA$30,713 | - |
| Device: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 | - |
| 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 |