Approval programs & pathways
2 programs · 2 pathwaysExpedited / special pathways
Priority ReviewConditional ApprovalOrphan Drug
Priority ReviewExpedited
Faster assessment for high-need medicines.
Eligibility · Major therapeutic advance
Conditional ApprovalConditional
Provisional approval on early clinical data.
Eligibility · Unmet need
Submission pathways · illustrative timelines & fees
CTA1 mo
Biologics · Agency fee
Clinical Trial Notification / Approval scheme.
NDA14 mo
Small molecules · Agency fee
Registration on the ARTG.