Evidence & policy library
Every pathway is linked to the organizations responsible for the decision.
17 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: 22
Market / scopeOfficial evidence recordTypePolicy / reference dateLast checked
APAC
🇯🇵 JapanOfficialreview disciplines, experts, re-examinationcurrent frameworkLatest observed: checked live
🇯🇵 Japan
OfficialSelected licensing, product-approval and GMP procedure; provisional August2025 English reference, Japanese original prevails.2025-08Latest observed: 2025-08
🇯🇵 JapanOfficialdossier, 60/90 days, organization, appeal, Chuikyo, supply, recalculationeffective 2026-04-01Latest observed: notice 2026-02-13
🇯🇵 JapanOfficialinitial pricing, market price, recalculation, PMP, CEA, mature lifecycleeffective 2026-04-01Latest observed: notice 2026-02-13
🇯🇵 Japan
Officialvisual overview of comparison/cost methods and process2025 discussion materialLatest observed: 2025
🇯🇵 Japan
Officialpost-listing use, target, analysis stages, ICER adjustment2026-03-05 versionLatest observed: 2026-03-05
🇯🇵 JapanOfficialprice-adjustment purpose and target criteriacurrent explainerLatest observed: checked live
🇯🇵 JapanOfficial2026 reform, SPA-SSS, supply support, generic/mature-product policy2026-03-05Latest observed: 2026-03-05
🇯🇵 JapanOfficialtemporary fee-for-service treatment for qualified cases2026-02-13Latest observed: 2026-02-13
🇯🇵 JapanOfficialhospital/regional formulary definition and non-mandatory boundarynotices 2023-07-07 and 2026-03-30Latest observed: checked live
🇯🇵 Japan
Officialhospital/regional formulary definition and non-mandatory boundarynotices 2023-07-07 and 2026-03-30Latest observed: checked live
🇯🇵 Japan
Officialhospital/regional formulary definition and non-mandatory boundarynotices 2023-07-07 and 2026-03-30Latest observed: checked live
🇯🇵 JapanOfficialAge and income-based patient caps, August-July annual period and repeated-case protectionMonthly and annual caps from2026-08; later phase2027-08Latest observed: 2026-07-31
🇯🇵 Japan
OfficialAge and income-based patient caps, August-July annual period and repeated-case protectionMonthly and annual caps from2026-08; later phase2027-08Latest observed: 2026-07-31
🇯🇵 JapanOfficialListed medicine codes, unit prices, brand/generic flags and transitional-use dateseffective 2026-10-14Latest observed: 2026-10-14
🇯🇵 JapanOfficialsubmission package and post-listing supply reporteffective 2026-04-01Latest observed: notice 2026-02-13
🇯🇵 JapanOfficialPMP product and company eligibility, maintenance method and statutory exceptionsEffective 2026-04-01; PMP chapter9Latest observed: Notice2026-02-13
🇯🇵 JapanOfficialConditional approval eligibility, PMDA consultation, post-approval obligations and old-rule transitionNotice 2026-02-27; effective 2026-05-01; Q&A 2026-04-30Latest observed: 2026-04-30
🇯🇵 JapanOfficialConditional approval eligibility, PMDA consultation, post-approval obligations and old-rule transitionNotice 2026-02-27; effective 2026-05-01; Q&A 2026-04-30Latest observed: 2026-04-30
🇯🇵 JapanOfficialConditional approval eligibility, PMDA consultation, post-approval obligations and old-rule transitionNotice 2026-02-27; effective 2026-05-01; Q&A 2026-04-30Latest observed: 2026-04-30
🇯🇵 JapanOfficialDesignation cohorts, 270-day company period including prior consultation, H5 related items and procedure boundariesNotice 2026-02-13; medicines effective 2026-04-01Latest observed: 2026-02-13
🇯🇵 Japan
OfficialFY2026 new-medicine total-review performance targets and statistical reporting conditions; not a product-specific approval guaranteeFY2026 annual plan; statistics note for applications from 2026-10-01Latest observed: FY2026
For education only — not regulatory, pricing or legal advice.