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
- MHLW Sets Up Global Strategy HQ to Bolster Innovation Ecosystem
June 28, 2024
- MHLW Panel OKs Different Safety Scheme for Fujimoto’s Revlimid Generic despite Concerns
June 27, 2024
- Constitutional Democratic Party Calls for Scrapping Off-Year Price Revisions
June 27, 2024
- Sakigake Tag to Be Withdrawn for Lisata’s Cell Therapy CLBS12
June 27, 2024
- Health Minister Set to Meet Generic Execs to Hear Views on Industry Revamp
June 26, 2024
- Japan's First Eylea Biosimilar Wins Nod, Potential Listing in November
June 25, 2024
- 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
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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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