Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Issues Guidelines on Package Insert Updates Mandated under Revised PAL
The Ministry of Health, Labor and Welfare (MHLW) has issued guidelines listing tips for drug makers to update package inserts based on the latest scientific knowledge - a new requirement under the revised Pharmaceutical Affairs Law (PAL) to be enforced…
To read the full story
Related Article
REGULATORY
- 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
- Hernexeos, Rinvoq, Tukysa Label Expansions Now in Line for Japan Approval
October 22, 2026
- LDP, Ishin Resume Social Security Talks, Chuikyo Reform to Follow
October 22, 2026
- LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
October 20, 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…