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

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.