Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Post-Shipment Quality Control Testing of Radiopharmaceuticals Would Not Violate GMP: MHLW
The Pharmaceutical and Food Safety Bureau’s Compliance and Narcotics Division and Evaluation and Licensing Division issued to prefectural governments a joint administrative communication that presents the Ministry of Health, Labor and Welfare’s (MHLW) views on the management of shipments of…
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
- 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
- Panel Backs RSV Antibodies for Japan’s Routine Immunization Program
October 23, 2026
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…