Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
REGULATORY
MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
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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