Evidence & policy library
Every pathway is linked to the organizations responsible for the decision.
16 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: 30
Market / scopeOfficial evidence recordTypePolicy / reference dateLast checked
Europe
🇫🇷 FranceOfficialinnovative-product AMM and France validityEU legal frameworkLatest observed: current
🇫🇷 FranceOfficialnational safety, exceptional access, supply boundarycurrentLatest observed: checked live
🇫🇷 FranceOfficialCT role, SMR/ASMR, final decision boundarycurrentLatest observed: 2024-11-10
🇫🇷 FranceOfficialCT role, SMR/ASMR, final decision boundarycurrentLatest observed: 2024-11-10
🇫🇷 FranceOfficialSMR/ASMR levels, lists, indication specificity, reassessmentcurrent doctrineLatest observed: checked 2026-08-01
🇫🇷 FranceOfficialSMR/ASMR levels, lists, indication specificity, reassessmentcurrent doctrineLatest observed: checked 2026-08-01
🇫🇷 FranceOfficialSMR/ASMR levels, lists, indication specificity, reassessmentcurrent doctrineLatest observed: checked 2026-08-01
🇫🇷 FranceOfficialfinal roles, 100/65/30/15, patient dispensingcurrentLatest observed: 2024-08-02 / 2026-06-18
🇫🇷 FranceOfficialfinal roles, 100/65/30/15, patient dispensingcurrentLatest observed: 2024-08-02 / 2026-06-18
🇫🇷 FranceOfficialprice, remises, volume, 180-day target, lifecyclecurrentLatest observed: CEPS page 2026-06-03
🇫🇷 FranceOfficialprice, remises, volume, 180-day target, lifecyclecurrentLatest observed: CEPS page 2026-06-03
🇫🇷 FranceOfficialASMR I–III, €20m/ATMP/organisation, efficiency/BIAdoctrine 2021; criteria effective 2023Latest observed: report 2026-04
🇫🇷 FranceOfficialASMR I–III, €20m/ATMP/organisation, efficiency/BIAdoctrine 2021; criteria effective 2023Latest observed: report 2026-04
🇫🇷 FranceOfficialfour criteria, pre/post-AMM, PUT-RD, 2026 guide; purpose-specific dossier models and October 2026 renewal-template transitionsreform from 2021-07-01Latest observed: 2026-09-01
🇫🇷 FranceOfficialcompassionate vs early access boundariesreform 2021Latest observed: ministry updated 2026
🇫🇷 FranceOfficialcompassionate vs early access boundariesreform 2021Latest observed: ministry updated 2026
🇫🇷 FranceOfficialeligibility, 100%, one year, continuity, reconciliationextended by LFSS 2026Latest observed: 2026-06-01
🇫🇷 FranceOfficialGHS exception, indication listing/radiation, codingcurrent legal frameworkLatest observed: ameli current 2026
🇫🇷 FranceOfficialGHS exception, indication listing/radiation, codingcurrent legal frameworkLatest observed: ameli current 2026
🇫🇷 FranceOfficiallocal formulary, PUI, hospital executioncurrent legal referencesLatest observed: guide 2026-05-05
🇫🇷 FranceOfficiallocal formulary, PUI, hospital executioncurrent legal referencesLatest observed: guide 2026-05-05
🇫🇷 FranceOfficialpatient payment, generic/biosimilar, mature-market codingcurrentLatest observed: 2026-06-18 / current
🇫🇷 FranceOfficialpatient payment, generic/biosimilar, mature-market codingcurrentLatest observed: 2026-06-18 / current
🇫🇷 FranceOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇫🇷 FranceOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇫🇷 FranceOfficialscope declaration, parallel notification, product-specific upload and submission-date changes2026-08-19Latest observed: 2026-09-02
🇫🇷 FranceOfficialvoluntary participation, initial-application window, readiness dialogue and Letter of Intent milestones2026-08-28Latest observed: 2026-09-07
🇫🇷 FranceOfficialvoluntary participation, initial-application window, readiness dialogue and Letter of Intent milestones2026-08-28Latest observed: 2026-09-07
🇫🇷 FranceOfficialEU-level pre-JCA request window, product eligibility, platform deadline and national-reimbursement boundary2025-11-28 annual programme; 2026-09-22 announcementLatest observed: 2026-09-22
🇫🇷 FranceOfficialEU-level pre-JCA request window, product eligibility, platform deadline and national-reimbursement boundary2025-11-28 annual programme; 2026-09-22 announcementLatest observed: 2026-09-22
For education only — not regulatory, pricing or legal advice.