Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- First Generics Joining NHI Price List in June Hits Record Low, Bridion is Only Target
June 14, 2024
- MHLW Proposes Supply Info System for All Prescription Drugs, FY2027 Launch Eyed
June 14, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- Tezspire Braced for CEA Price Cut, AstraZeneca's Appeal Dismissed
June 13, 2024
- LDP Members Urge Modification of Honebuto Draft to Push Rethink of Off-Year Drug Price Cuts
June 13, 2024
- Social Security Budget Ceiling Looks Set to Continue 3 More Years: Honebuto Draft
June 12, 2024
- Honebuto Draft Equivocal on Off-Year Price Cuts, but Focuses on FY2025 Revision
June 12, 2024
- Label Revisions Ordered for Brimonidine, Finerenone, and More
June 12, 2024
- MHLW to Issue Nitrosamine Risk Communication Guidance by June-End; Draft Now Ready
June 11, 2024
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
- Japan Enacts Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
June 11, 2024
- Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
June 10, 2024
- MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- LDP Policy Board Endorses Fiscal Consolidation HQ’s Proposal to Extend CEAs
June 10, 2024
- Japan Grants Orphan Tag to Cannabidiol, 6 More APIs
June 10, 2024
- Health-Savvy Lawmakers Urge Revamp of Off-Year Revisions: LDP Policy Panel
June 7, 2024
- Abolish Off-Year Revisions, No to Broader CEA Use: Eto Group to Ministers
June 7, 2024
- LDP League on Medical Patches Urges Clarification of “Medical Necessity” as New Coverage Rule Looms
June 7, 2024
- Japan Eases Rule on Regulatory Submissions for Combination Therapies
June 6, 2024
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Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…