Evidence & policy library
Every pathway is linked to the organizations responsible for the decision.
18 source records
Methodology
Pathway information draws on official regulator, HTA and payer materials. Consult the cited policy for its conditions and effective date, and see Content & use for guidance on applying Atlas to your research.
Matching documents: 34
Market / scopeOfficial evidence recordTypePolicy / reference dateLast checked
Europe
🇩🇪 GermanyDE-S01 · EMA / EC · Authorisation of medicines; pre-authorisation guidanceOfficialcentralised scope, CHMP/EC roles, EU validityEU centralised legal frameworkLatest observed: current🇩🇪 GermanyDE-S01 · EMA / EC · Authorisation of medicines; pre-authorisation guidanceOfficialcentralised scope, CHMP/EC roles, EU validityEU centralised legal frameworkLatest observed: current🇩🇪 GermanyDE-S02 · BfArM · National procedure; Decentralised ProcedureOfficialBfArM/PEI boundary, DCP/MRP/nationalcurrent German proceduresLatest observed: checked live🇩🇪 GermanyDE-S02 · BfArM · National procedure; Decentralised ProcedureOfficialBfArM/PEI boundary, DCP/MRP/nationalcurrent German proceduresLatest observed: checked live🇩🇪 GermanyDE-S03 · G-BA · Benefit Assessment of Medicinal Products / Ablauf der frühen NutzenbewertungOfficialday-1 dossier, 3+3 months, ACT, month-7 priceAMNOG effective 2011-01-01Latest observed: current 2026🇩🇪 GermanyDE-S03 · G-BA · Benefit Assessment of Medicinal Products / Ablauf der frühen NutzenbewertungOfficialday-1 dossier, 3+3 months, ACT, month-7 priceAMNOG effective 2011-01-01Latest observed: current 2026🇩🇪 GermanyDE-S04 · G-BA / KBV · Additional-benefit categories; early benefit assessmentOfficialextent/certainty, subgroups, resolution fieldscurrentLatest observed: checked live🇩🇪 GermanyDE-S04 · G-BA / KBV · Additional-benefit categories; early benefit assessmentOfficialextent/certainty, subgroups, resolution fieldscurrentLatest observed: checked live🇩🇪 GermanyDE-S05 · G-BA · New medicines: procedural rules after EU assessmentOfficialEU JCA and national AMNOG linkage2025-07Latest observed: current implementation🇩🇪 GermanyDE-S06 · GKV-Spitzenverband · AMNOG negotiations §130b SGB VOfficialfirst 6 months, month 7, negotiation, price rules, mixed price, EU price removalcurrent rulesLatest observed: current through 2026🇩🇪 GermanyDE-S07 · BMG / GKV-SV · Medizinforschungsgesetz; confidential reimbursement amountOfficialR&D eligibility, 9%, confidential amount2024 law; option from 2025Latest observed: temporary to 2028-06-30🇩🇪 GermanyDE-S07 · BMG / GKV-SV · Medizinforschungsgesetz; confidential reimbursement amountOfficialR&D eligibility, 9%, confidential amount2024 law; option from 2025Latest observed: temporary to 2028-06-30🇩🇪 GermanyDE-S08 · G-BA · GKV-FinStG statutory tasks and orphan >€30m current casesOfficialorphan presumption/threshold/reassessmentthreshold change Nov 2022Latest observed: current 2026 cases🇩🇪 GermanyDE-S08 · G-BA · GKV-FinStG statutory tasks and orphan >€30m current casesOfficialorphan presumption/threshold/reassessmentthreshold change Nov 2022Latest observed: current 2026 cases🇩🇪 GermanyDE-S09 · German federal law · SGB V §130e — rebate contracts for therapeutically comparable patent-protected medicinesOfficialeligible classes, group definition, cross-active tender, prescribing preference and medical exceptioneffective 2026-07-30Latest observed: current consolidated law🇩🇪 GermanyDE-S10 · G-BA · Arzneimittel-RichtlinieOfficialoutpatient prescribing, restrictions, aut-idem, biosimilar, Annex XIIcurrent frameworkLatest observed: effective 2026-07-23🇩🇪 GermanyDE-S11 · KBV · Wirtschaftlichkeit; early benefit assessment and Praxisbesonderheit transitionOfficialprescribing economy, abolition for new §130b agreements, legacy transition and regional reviewcurrentLatest observed: reform effective 2026-07-30🇩🇪 GermanyDE-S11 · KBV · Wirtschaftlichkeit; early benefit assessment and Praxisbesonderheit transitionOfficialprescribing economy, abolition for new §130b agreements, legacy transition and regional reviewcurrentLatest observed: reform effective 2026-07-30🇩🇪 GermanyDE-S12 · BMG · Hospital financing; inpatient billingOfficialdual finance, DRG, ZE, bundled medicine costcurrentLatest observed: hospital page stand 2026-01-05🇩🇪 GermanyDE-S12 · BMG · Hospital financing; inpatient billingOfficialdual finance, DRG, ZE, bundled medicine costcurrentLatest observed: hospital page stand 2026-01-05🇩🇪 GermanyDE-S13 · InEK · NUB; 2026 information under §6(2) KHEntgGOfficiallocal NUB negotiation, ATMP supplement2026 cycleLatest observed: 2026-06-30🇩🇪 GermanyDE-S13 · InEK · NUB; 2026 information under §6(2) KHEntgGOfficiallocal NUB negotiation, ATMP supplement2026 cycleLatest observed: 2026-06-30🇩🇪 GermanyDE-S14 · G-BA · Application-accompanying data collection; ATMP-QS-RL; benefit-assessment FAQOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22🇩🇪 GermanyDE-S14 · G-BA · Application-accompanying data collection; ATMP-QS-RL; benefit-assessment FAQOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22🇩🇪 GermanyDE-S14 · G-BA · Application-accompanying data collection; ATMP-QS-RL; benefit-assessment FAQOfficialAbD, provider restriction, reassessment, ATMP qualitycurrentLatest observed: ATMP-QS effective 2026-04-22🇩🇪 GermanyDE-S15 · BMG / GKV-SV / G-BA · Drug co-payment and reimbursement; fixed amounts; aut-idemOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01🇩🇪 GermanyDE-S15 · BMG / GKV-SV / G-BA · Drug co-payment and reimbursement; fixed amounts; aut-idemOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01🇩🇪 GermanyDE-S15 · BMG / GKV-SV / G-BA · Drug co-payment and reimbursement; fixed amounts; aut-idemOfficialco-pay, fixed amount, substitution, mature phasecurrentLatest observed: checked 2026-08-01🇩🇪 GermanyDE-S16 · German federal law / BMG · SGB V §130b current text; GKV contribution-rate stabilisation reformOfficialmandatory price-volume terms, statutory fallback adjustment, transition and effective datelaw passed 2026-07-10; relevant provisions effective 2026-07-30Latest observed: current consolidated law🇩🇪 GermanyDE-S16 · German federal law / BMG · SGB V §130b current text; GKV contribution-rate stabilisation reformOfficialmandatory price-volume terms, statutory fallback adjustment, transition and effective datelaw passed 2026-07-10; relevant provisions effective 2026-07-30Latest observed: current consolidated law🇩🇪 GermanyDE-S17 · European Commission / EMA · EU JCA early-information guidance and EMA IRIS coordinationOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02🇩🇪 GermanyDE-S17 · European Commission / EMA · EU JCA early-information guidance and EMA IRIS coordinationOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02🇩🇪 GermanyDE-S17 · European Commission / EMA · EU JCA early-information guidance and EMA IRIS coordinationOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02🇩🇪 GermanyDE-S18 · German federal law · SGB V section 130b(7a): special termination windowOfficialeligible legacy agreements and awards, termination deadline and continued effect until replacementrelevant reform effective 2026-07-30Latest observed: termination deadline 2026-10-01For education only — not regulatory, pricing or legal advice.