Approval programs & pathways
2 programs · 2 pathwaysExpedited / special pathways
Rolling ReviewConditional ApprovalOrphan DrugPriority Review
Rolling ReviewExpedited
Rolling assessment of data as it becomes available.
Eligibility · Public-health need
Conditional ApprovalConditional
Conditional marketing authorisation with obligations.
Eligibility · Unmet need
Submission pathways · illustrative timelines & fees
CTA1 mo
Biologics · Agency fee
Clinical Trial Authorisation for UK trials.
MAA12 mo
Small molecules · Agency fee
UK Marketing Authorisation (national / international recognition).