Routes of the same type are on the same row. Compare other markets.
13 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.
Spain: Centralised marketing authorisation, new active substance, 210 days. Canada: New drug submission (new active substance), 300 days. These are official targets, not actual review times.
| Pathway type | Spain | Canada |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 |
| Full or mixed application, known active substance |
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.
New drug submission or supplement (known substance)NDS / SNDS · target 300 days · fee CA$319,282 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 |
| Biosimilar application | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 | Biosimilar new drug submissionNDS (biosimilar) · target 300 days |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| 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 |
| Traditional or herbal registration | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Notice of compliance with conditionsNOC/c · target 200 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Priority reviewPriority · target 180 days |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | - |
| Pediatric plan or incentive | Paediatric investigation plantarget 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 |
| Reliance route, recognition or verification | Mutual recognition procedure involving Spaintarget 90 days · relies on EU Mutual recognition proceduretarget 90 days | - |
| Work-sharing or joint review | Decentralized procedure with Spain as reference member statetarget 120 days · fee €17,073 Decentralised proceduretarget 210 days | 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: 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 |
| Other route | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days |