Recent non-conformity with PMD Act at pharmaceutical manufacturing sites and preventing measures for reoccurrence of such non-conformity

Abstract

In December 2020, many health damage incidents were caused by an oral antifungal drug—itraconazole 50 mg tablet—contaminated with active ingredients for sleeping pills, which was manufactured by Kobayashikako.co.,Ltd.. Subsequently, several non-conformities under the PMD Act were uncovered among other pharmaceutical manufacturers. This has led to an undermining of confidence in the quality of pharmaceuticals in Japan. The Ministry of Health, Labor, and Welfare has implemented various preventive measures for these non-conformities.