Routes of the same type are on the same row. Compare other markets.
12 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, non-prescription monograph and more. The table lines up the routes of each type.
Canada: New drug submission (new active substance), 300 days. These are official targets, not actual review times.
| Pathway type | Canada | Brazil |
|---|---|---|
| Full application, new active substance | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 | Registration of a new medicinefee R$157,416 |
| Full or mixed application, known active substance | New drug submission or supplement (known substance)NDS / SNDS · target 300 days · fee CA$319,282 |
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.
Registration of an innovative medicinefee R$37,231 |
| Generic application | Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 |
| 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 |
| 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 reviewPriority · target 180 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | - | Special procedure for new medicines for rare diseasestarget 60 days |
| 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 | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP |
| 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 | - | Notification of a class I or II medical devicetarget 30 days |
| 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 | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days |
| Other route | Good manufacturing practice certification (CBPF)target 365 days |