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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REGULATORY
- Japan Identifies 28 New “Drug Loss” Products from 2021-23 Approvals
April 7, 2026
- Japan OKs Zolgensma Intrathecal Form, Breyanzi Expansion, New EB Therapy
April 6, 2026
- Trump Signs Off on Up to 100% Tariffs on Drugs; Japan Rate Set at 15%
April 3, 2026
- Japan Launches Task Force to Secure Critical Supplies amid Middle East Crisis
April 3, 2026
- MHLW Streamlines Lot Release Procedures for Vaccines, Blood Products
April 3, 2026
- MHLW Allows Outer Packaging Labeling for Regenerative Medicine Products
April 3, 2026
- MHLW’s Drug Supply Monitoring System Now Up and Running
April 3, 2026
- MHLW Sets Up Contact Point on Medical Supply Risks Tied to Iran War
April 3, 2026
- LDP, Ishin Call for Proper Valuation in CEA Scheme at Reform Talks
April 3, 2026
- MHLW Revises Biological Raw Material Rules, Clarifies Donor Testing Flexibility
April 2, 2026
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
- MHLW, METI Launch Joint Task Force to Safeguard Medical Supply Chains
April 1, 2026
- Japan Urges Priority Supply of Petroleum-Based Materials for Medical Devices
March 31, 2026
- Japan’s New HIV Cases Hit 20-Year Low in 2025
March 30, 2026
- MHLW Launches Genomic Medicine Body GeMJ
March 30, 2026
- TNF Inhibitors, Cancer Drugs Flagged in PMDA Risk Review
March 30, 2026
- Japan Ranks 9th Among 10 in AI Analysis of EFPIA Pharma Strategy Report
March 27, 2026
- MHLW Says Trial Recruitment Info Not Deemed Advertising Under PMD Act
March 27, 2026
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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…