Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Shock, Anaphylaxis Added to Xofluza’s ADR List; Label Changes for Checkpoint Blockers
The Ministry of Health, Labor and Welfare (MHLW) on June 4 ordered label revisions related to adverse reactions for a batch of drugs including Shionogi’s novel flu drug Xofluza (baloxavir marboxil) and immune checkpoint inhibitors. Xofluza will add shock and…
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REGULATORY
- Council Floats 9.6% Growth Target for Japan’s On-Patent Drug Market
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- MHLW Approves Towa Generics for Revolade, Vimpat
March 11, 2026
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
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March 9, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…