The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Proposes “Institutionalization” of Conditional Approval, Sakigake Schemes
With an eye on an amendment of the Pharmaceuticals and Medical Devices (PMD) Law, the health ministry has proposed the “institutionalization” of its conditional early approval system and sakigake fast-track designation scheme under the law in order to give them…
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