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
MHLW Designates Ceritinib as Orphan Drug
The Ministry of Health, Labor and Welfare (MHLW) has designated Novartis Pharma’s ceritinib as an orphan drug. The proposed indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive unresectable, advanced or relapsed non-small cell lung cancer who…
To read the full story
REGULATORY
- MHLW to Discuss Faster MCM Approvals during Health Emergencies
October 26, 2026
- Foreign Price Adjustment Rule a Key Issue in Japan’s MFN Response: Official
October 26, 2026
- MHLW Official Vows Crackdown on Illegal Mounjaro Sales
October 26, 2026
- Temodal, Topotecin Gain NHI Coverage for Neuroblastoma Combo Therapy
October 26, 2026
- Japan Approves OTC Version of Taiho’s Allergy Drug Bilanoa
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…
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…
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…