REGULATORY

MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions

By Ken Yoshino June 10, 2024

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The Ministry of Health, Labor and Welfare (MHLW) has proposed stipulating in the Pharmaceuticals and Medical Devices (PMD) Act that it is possible to file for regulatory approval of drugs based on real-world clinical data alone. The proposal was made…

To read the full story

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Chuikyo Debate on FY2026 Drug Pricing Reform

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COMMENTARY

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

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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…