Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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