Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ICH Completes Guidelines for Multiregional Clinical Trials; Could Accelerate Simultaneous Global Development
The International Council for Harmonization’s (ICH) new guidelines on multi-regional clinical trials (E17) reached Step 4 (Adoption of an ICH Harmonized Guideline) at an ICH meeting held on November 11-16 in Geneva, the Ministry of Health, Labor and Welfare (MHLW)…
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REGULATORY
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 2026
- MHLW Orders Label Revisions for Cancer Drugs, Anticoagulant over Bleeding Risk
March 9, 2026
- Japan Health Minister Lauds Approval of iPSC-Based Therapies
March 9, 2026
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…