Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Trade Groups Urge Pricing Overhaul for Regenerative Medicines, Biotech Drugs
A group of companies developing regenerative medicine products on July 9 called for reforms to Japan’s drug pricing system, arguing that current frameworks fail to reflect the high manufacturing costs and unique characteristics of these therapies. At an industry hearing…
To read the full story
Related Article
- FIRM Calls for Pricing Overhaul to Reflect Unique Benefits of Regenerative Therapies
September 18, 2025
- Generic and Wholesaler Groups Call for Pricing Reforms to Reflect Inflationary Pressures
July 11, 2025
- 16 Drugs Enter Japan Trials after Pro-Innovation Reform: Industry Poll
July 10, 2025
- Pharma Groups Renew Push for Price Stability During Patent Term as FY2026 Reform Talks Begin
July 10, 2025
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
- 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
- Japan Weighs Possible Approval Revocation for Tavneos, Action Against Kissei
October 22, 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…