REGULATORY

MHLW to Accept Applications for COVID-19 Treatments Without Clinical Trial Data; Avigan, Alvesco, Futhan Might Be Eligible

May 14, 2020

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The Ministry of Health, Labor and Welfare (MHLW) issued a notification on May 12, informing that applications for COVID-19 infection treatments might be accepted without clinical trial results if a certain degree of their efficacy and safety are confirmed in…

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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands

By Shinya Sato

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

By Philip Carrigan

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…