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

Are Technical Discussions Enough for Japan’s CEA System?

By Ken Yoshino

Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…

COLUMN

The Patient North Star: How Gilead Japan Redefined Innovation

By Philip Carrigan

In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…