1
EU marketing authorizationEMA / European Commission
Output: Union marketing authorization
Scope: Approved indication across EU/EEA as applicable
Compare market pathways
Align systems by decision stage without forcing them into one universal route.
Germany
France
🇩🇪 Germany：GKV access begins at launch, while AMNOG benefit assessment and reimbursement negotiation determine the later price; the 2026 reform adds mandatory price-volume terms and fund-specific patent-group contracting.; 🇫🇷 France：SMR determines reimbursement relevance/rate, ASMR informs price, CEESP is conditional, and community and hospital funding routes diverge.
RegulatoryHTA / assessmentPrice / negotiationCoveragePost-listing
Germany
GKV access begins at launch, while AMNOG benefit assessment and reimbursement negotiation determine the later price; the 2026 reform adds mandatory price-volume terms and fund-specific patent-group contracting.
2
AMNOG dossier at first placing on marketManufacturer / G-BA
Output: Evidence package for added-benefit assessment
Scope: GKV target population and comparator subgroups
3
Zusatznutzen resolutionG-BA
Output: Binding added-benefit resolution by subgroup
Scope: GKV price negotiation and prescribing information
4
Erstattungsbetrag and price-volume termsGKV-Spitzenverband / manufacturer
Output: National reimbursement amount plus negotiated or statutory price-volume rule
Scope: GKV supply; negotiated scope and statutory rules
5
Patent-group rebate contract branchSickness fund / association / prescriber
Output: Tendered contract and preferred medicine within an eligible therapeutic group
Scope: Fund/group/product-specific; medical exception remains
6
NUB / ZE hospital fundingInEK / hospitals / sickness funds
Output: Temporary innovation status or additional payment route
Scope: Named hospital, case and DRG context
France
SMR determines reimbursement relevance/rate, ASMR informs price, CEESP is conditional, and community and hospital funding routes diverge.
1
AMMEMA / ANSM
Output: Marketing authorization
Scope: Approved indication
2
Avis CT: SMR / ASMRHAS Commission de la transparence
Output: Reimbursement relevance/rate advice and added-value grade
Scope: Indication and target population
3
Convention de prixCEPS / manufacturer
Output: Price and contractual clauses
Scope: Covered presentation and indication economics
4
Inscription / taux / publicationMinistries / UNCAM
Output: Reimbursement listing, rate and effective public notice
Scope: Specified community or hospital route
5
AAP / AAC / CPCHAS / ANSM / Ministry
Output: Defined early-access authorization and funding conditions
Scope: Mechanism-specific patients and timing