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, generic application, biosimilar application, non-prescription application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
Canada: New drug submission (new active substance), 300 days. Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), 280 days. These are official targets, not actual review times.
| Pathway type | Canada | Saudi Arabia |
|---|---|---|
| Full application, new active substance | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 | Marketing authorization for a new drug or biologic (regular review)target 280 days · fee SAR 95,000 |
| 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.
Registration of a generic medicinetarget 155 days · fee SAR 40,000 |
| 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 | Over-the-counter status and switch from prescriptiontarget 100 days |
| 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 | Priority reviewtarget 168 days |
| Intensive development support designation | - | Breakthrough Medicine Programtarget 60 days Research and Investigational Drugs (RAID) designationtarget 40 days |
| 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 | Abridged pathway (approved by US FDA or EMA)target 60 days · relies on US, EU |
| Reliance route, recognition or verification | - | Verification pathway (approved by both US FDA and EMA)target 30 days · relies on US, EU |
| 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 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 | Medical Device Marketing Authorization (MDMA)MDMA · target 35 days · fee SAR 23,000 |
| Device: breakthrough or priority program | - |
| Other route | - |