Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Doles Out Orphan Tags for 10 APIs, Pulls Status for Biogen’s MS Drug
Japan’s Ministry of Health, Labor and Welfare (MHLW) on August 28 designated 10 APIs as orphan drugs while withdrawing such designation for Biogen Japan’s multiple sclerosis (MS) treatment fampridine. Fampridine had been designated as an orphan drug in March 2016…
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REGULATORY
- MHLW Revises Biological Raw Material Rules, Clarifies Donor Testing Flexibility
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April 1, 2026
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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…