PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
Regulatory Reform Council Selects “Switch-OTC In Vitro Diagnostics” as Target for “International Benchmark Test”
The government’s Regulatory Reform Council (chairman: Motoyuki Oka, Senior Advisor, Sumitomo Corporation) selected “switch-OTC in vitro diagnostics” at a meeting on February 4 as a target for the “international benchmark test” it applies to strategic fields to assess the necessity…
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REGULATORY
- MHLW to Discuss Faster MCM Approvals during Health Emergencies
October 26, 2026
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October 26, 2026
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October 26, 2026
- Temodal, Topotecin Gain NHI Coverage for Neuroblastoma Combo Therapy
October 26, 2026
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October 26, 2026
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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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…
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…