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Before

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.

After

このページは、厚生労働省がギリアド・サイエンシズ インクに対して、医薬品医療機器法に基づく業務改善の指示を行ったことを発表しています。この指示は、同社が治験中に国外で発生した副作用を所定の期限内に報告しなかったことを受けており、適切な副作用報告体制の確保を求めています。ただし、国内と国外で行われた治験による副作用については、適切に報告がなされており、現時点で新たな安全性上の重大な懸念は存在しません。