www.mhlw.go.jp/stf/houdou/0000179072.html

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バイエル薬品株式会社に対し、副作用報告義務違反への改善指導を行いました｜厚生労働省

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https://www.mhlw.go.jp/stf/houdou/0000179072.html

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This page announces that Japan's Ministry of Health, Labour and Welfare issued improvement guidance to Bayer Yakuhin Ltd. for violations of adverse event reporting obligations. The company failed to report 86 cases of adverse effects from four drugs: Exarelto, Bayaspirin, Stivarga, and Nexavar, with delays up to approximately 4 years and 11 months. Violations resulted from insufficient employee awareness, redundant reporting confirmation issues, improper causality judgments, and inadequate self-inspection scope. No immediate safety measures were deemed necessary.