REGULATORY

Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel

June 4, 2024

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The Japanese government’s regulatory reform promotion council proposed making the use of a single institutional review board (IRB) mandatory in publicly funded joint drug research as part of its recommendations submitted to Prime Minister Fumio Kishida on May 31. In…

To read the full story

Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
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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…