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
- Health Ministry Changes Avigan Approval Conditions
June 25, 2024
- Japan Approves Novartis’ Fabhalta, Lilly’s Jaypirca, and Lots More
June 25, 2024
- Japan OKs Honebuto Paper, Modest Wording on Off-Year Revisions Finalized
June 24, 2024
- Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
June 24, 2024
- PMDA Reviewing Safety Risks for Duvroq, Opdivo, and More
June 24, 2024
- Japan Panel Raises No Objection to Public Coverage of Shingles Vaccines
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- Xevinapant Earns Sakigake Tag, 6 APIs Get Orphan Status
June 20, 2024
- Opposition Party Urges Health Minister to Scrap Off-Year Drug Price Revision
June 19, 2024
- MHLW to Bankroll Up to 50 Billion Yen Each to KM, Daiichi for Vaccine Trials
June 19, 2024
- Nitrosamine Risk Communication Guidance Issued, Effective Immediately
June 19, 2024
- LDP Tweaks Honebuto Text on Off-Year Revision, Waters Down Push for CEA Expansion
June 18, 2024
- ICH Agrees to Draft Nitrosamine Guideline, Aims to Set Acceptable Intakes
June 18, 2024
- PMDA Chief Strenuously Delivering Info on Japan Regulations at Overseas Confabs
June 17, 2024
- 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
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