www.mhlw.go.jp/stf/houdou/0000096173.html

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「製造販売後安全管理業務に係る社内体制等に関する自主点検」の結果を公表します｜厚生労働省

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https://www.mhlw.go.jp/stf/houdou/0000096173.html

About this page

This page presents the results of a self-inspection conducted by the Ministry of Health, Labour and Welfare in September 2015 regarding post-market safety management practices at pharmaceutical manufacturers. The inspection found operational manual deficiencies in 20 companies, all of which have been corrected. Additionally, 5 companies had unreported adverse event information totaling 46 cases (69 incidents). While no additional safety measures were required, the ministry directed these companies to report the causes and improvement measures for the reporting delays to prevent recurrence.