Approval programs & pathways
2 programs · 2 pathwaysExpedited / special pathways
Priority ReviewConditional ApprovalOrphan Drug
Priority ReviewExpedited
Shortened review for serious-condition therapies.
Eligibility · Serious condition + benefit
Conditional ApprovalConditional
NOC/c on promising evidence with confirmatory obligations.
Eligibility · Unmet need
Submission pathways · illustrative timelines & fees
CTA1 mo
Biologics · Agency fee
Clinical Trial Application to Health Canada.
NDA13 mo
Small molecules · Agency fee
New Drug Submission (NDS) for marketing.