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 Panel OKs Report on Clinical Trials, Calls for Model Project on FMV Cost Approach
June 13, 2025
- Latest Honebuto Draft Erases “Expansion” of CEA after LDP Pushback
June 12, 2025
- EquMet, Clenafin See Generic Entry in June Listing
June 12, 2025
- Ruling Bloc, Ishin Agree to Discuss Coverage of OTC-Like Drugs
June 12, 2025
- Include Repeal of Off-Year Drug Price Revision in Honebuto: DPP
June 12, 2025
- GSK’s Arexvy Bolsters Label with Long-Term Data
June 11, 2025
- LDP Lawmakers Push Back on Honebuto Draft over CEA, Social Security Budgeting
June 10, 2025
- Honebuto Draft Urges Promotion of Drug Innovation, but Spells Out CEA Expansion Too
June 9, 2025
- MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Now in Line for Japan Approval
June 9, 2025
- MHLW to Share Guidelines on Order to Replace Company Officers under Amended PMD Act
June 9, 2025
- 3 Parties Agree to Review OTC-Like Drugs from FY2026, but Details Still in the Air
June 9, 2025
- MHLW Revises Q&A on Nitrosamine Self-Inspections, OKs Use of Interim Control Limit
June 5, 2025
- MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
June 5, 2025
- Early Honebuto Draft Contains CEA Expansion, Ramp-Up of FIH Trial Sites
June 4, 2025
- New Skipper of PMDA’s Review Center Wears Multiple Hats to Push Fight against Drug Loss
June 2, 2025
- LDP Group Urges Ministers to Keep Coverage of Pain Relief Patches
June 2, 2025
- PMDA Reviewing Safety Risks of Thiamazole, Desmopressin
June 2, 2025
- Japan Selects JN.1 Substrains for COVID Vaccines in 2025-2026 Season
May 30, 2025
- Regulatory Reform Panel Calls for Review of Clinical Trial Ad Rules
May 30, 2025
- Ishin Nixes Ruling Bloc’s Draft Social Security Plans over OTC-Like Drug Issue
May 30, 2025
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