REGULATORY

MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement

January 6, 2026

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The Ministry of Health, Labor and Welfare (MHLW) has issued a notification outlining the intent and key elements of amendments to the Pharmaceuticals and Medical Devices (PMD) Act, which are set to take effect on May 1. Dated December 26,…

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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

A “Core Industry” in Name Only? Drug Pricing Reform Leaves a Sour Taste

By Ken Yoshino

Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…

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…