REGULATORY

PMDA Will Prosper by Promoting Review Work, Research, and Training Together: Chief Executive

August 13, 2014

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With 2014 marking 10 years since the inception of the Pharmaceuticals and Medical Devices Agency (PMDA), Jiho interviewed Tatsuya Kondo, who has served as chief executive since 2008. Initially, his appointment to the post was met with surprise as he…

To read the full story

PMDA Chief Kondo to Step Down after 11 Years in Charge
March 25, 2019

REGULATORY

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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…