Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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REGULATORY
- LDP Health Panel Approves Health Insurance Bill with OTC-Like Drug Charges
March 5, 2026
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
- MHLW Clarifies Up to 12-Year Data Protection for Pediatric Development
March 2, 2026
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Executives Urge Stronger CDMO, CRO Base at Drug Discovery WG Meeting
February 27, 2026
- Japan to Closely Monitor US “MFN” Policy: PM Takaichi
February 27, 2026
- Japan to Update Adult Pneumococcal Fact Sheet Ahead of Capvaxive NIP Review
February 27, 2026
- Takaichi Signals Continued Off-Year Revisions despite Abolition Calls
February 26, 2026
- LDP Panel Delays Approval of Health Insurance Bill amid Concerns over OTC-Like Drug Charges
February 26, 2026
- MHLW Orders Colchicine Label Revision, Warns against Doses above 1.5 mg per Day
February 26, 2026
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 2026
- Japan Panel to Review Haihe’s PI3Kα Inhibitor, MSD’s HIV Med, and More on March 2
February 24, 2026
- PM Vows Comprehensive Support for 17 Priority Sectors: Policy Speech
February 24, 2026
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Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…