www.mhlw.go.jp/stf/houdou/0000102311.html
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医薬品医療機器法違反業者に対する行政処分を行いました｜厚生労働省
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https://www.mhlw.go.jp/stf/houdou/0000102311.html
About this page
This page announces that the Ministry of Health, Labour and Welfare issued an administrative order against Novartis Pharma K.K. for violations of the Pharmaceutical Affairs Law. Due to a malfunction in the adverse event reporting system, the company failed to report 5,475 adverse event cases for 57 prescription drugs it manufactures and sells, resulting in a business improvement order. Additionally, 154 adverse event reporting violations related to 28 investigational drugs were identified, leading to a business improvement instruction.
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