Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Diuretic, Hypertension Drugs, Zolgensma under PMDA Risk Review
The Pharmaceuticals and Medical Devices Agency (PMDA) is looking into new safety risks for a long list of diuretic agents and hypertension treatments as well as Novartis Pharma’s gene therapy Zolgensma (onasemnogene abeparvovec), flagging label changes in the near future.…
To read the full story
Related Article
- MHLW Orders Label Revisions for Diuretics, Zolgensma
May 22, 2025
REGULATORY
- 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
Japan will overhaul its R&D tax credit regime in its FY2026 reform, introducing a new strategic category alongside existing frameworks.…
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
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…