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…

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COMMENTARY

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COLUMN

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