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. Canada: New drug submission (new active substance), 300 days. These are official targets, not actual review times.
| Pathway type | China | Canada |
|---|---|---|
| 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 | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 |
| 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 | 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 | Nonprescription (OTC) drug applicationtarget 200 days | DIN application with supporting dataDINA / DINB · target 210 days · fee CA$319,282 |
| 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 |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | Priority review and approvaltarget 130 days | Priority reviewPriority · target 180 days |
| Intensive development support designation | - |
| Rolling or phased review | - |
| 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 | 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 |
| 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 |
| 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: 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 | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 |
| Device: breakthrough or priority program | - |
| Other route |