Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Review Application of Emergency Approval System after COVID Downgrade
The Ministry of Health, Labor and Welfare (MHLW) will review how it applies the emergency approval system, which was used to approve Shionogi’s COVID-19 pill Xocova (ensitrelvir) last year, in view of the scheduled downgrading of the disease’s severity status…
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REGULATORY
- Gaku Hashimoto to Return as Skipper of LDP Team on Drug Innovation
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- Japan Cabinet Approves Health Insurance Bill with OTC-Like Drug Charges
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- LDP Urges Action on Drug Supply Risks Linked to Reliance on Specific Countries
March 16, 2026
- 874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…