Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Expresses Distrust of MSD for Deviations from GCP in Trials of Gardasil
The new drug application (NDA) review report issued on the cervical cancer vaccine Gardasil (human papillomavirus quadrivalent vaccine, recombinant), approved on July 1, has revealed that a number of problems were found in clinical trials conducted in Japan and abroad…
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REGULATORY
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Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
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