www.mhlw.go.jp/stf/houdou/0000073914.html
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医薬品医療機器法に基づく業務改善指示を行いました｜厚生労働省
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https://www.mhlw.go.jp/stf/houdou/0000073914.html
About this page
This page announces that the Ministry of Health, Labour and Welfare issued a business improvement order to Gilead Sciences Inc. on February 13, 2015, based on the Pharmaceuticals and Medical Devices Law. The order was issued because the company failed to report adverse effects occurring post-market in foreign countries within the prescribed timeframe during clinical trials. The ministry instructed improvements in trial operations to ensure proper adverse effect reporting systems. Adverse effects from clinical trials in Japan and abroad have been properly reported, and all delayed information has been supplemented, with no new safety concerns identified.
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