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European Medicines Agency
EU centralised authority for human & veterinary medicines.
Approval programs & pathways
4 programs · 3 pathwaysExpedited / special pathways
PRIMEAccelerated ApprovalConditional ApprovalOrphan DrugRolling ReviewPediatric
PRIMEExpedited
PRIority MEdicines — enhanced support for products addressing unmet need.
Eligibility · Major therapeutic advantage / unmet need
Conditional ApprovalConditional
Authorisation on less comprehensive data with specific obligations.
Eligibility · Unmet need + positive benefit-risk
Accelerated ApprovalExpedited
Accelerated assessment (150 days) for major public-health interest.
Eligibility · Major public-health interest
Orphan DrugOrphan
Incentives for rare-disease medicines (<5 in 10,000).
Eligibility · Rare-disease prevalence
Submission pathways · illustrative timelines & fees
CTA2 mo
Biologics · Member-state fee
Clinical Trial Application via CTIS under EU CTR 536/2014.
MAA13 mo
Biologics · Centralised procedure fee
Marketing Authorisation Application via the centralised procedure (CHMP opinion).
Orphan drug application3 mo
Rare diseases · Reduced / fee waiver
Orphan designation via COMP.
EMA
European Medicines Agency
Supranational agency · Netherlands
Live record · illustrative seed data · scores deterministic, rules-based — not AI.