Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
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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