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Before

This page is a press release from Japan's Ministry of Health, Labour and Welfare dated October 4, 2016. It announces that the ministry conducted an unannounced inspection of the General Incorporated Foundation Institute for Serological Science on September 6-7 and discovered that Ensepack (dried cell culture Japanese encephalitis vaccine) was manufactured differently from its approved manufacturing authorization. The ministry issued reporting orders and improvement orders under the Pharmaceutical Affairs Law. However, the final product's quality and safety were confirmed to be unaffected.

After

このページは、厚生労働省が一般財団法人化学及血清療法研究所に対して報告命令を発出したと発表した内容を伝えています。立入検査の結果、エンセバック皮下注用ワクチンの製造が製造販売承認書の記載と一部異なっていたことが確認されましたが、最終製剤の品質や安全性には影響がないとされています。報告命令は医薬品医療機器法に基づき行われ、改善命令や弁明の機会も付与されています。