2021.03.24 09:44Nation

日医工を立ち入り調査 後発薬不正製造で業務停止―富山県など

 国の承認を得ていない方法で医薬品を製造したなどとして、富山県が業務停止命令を出しているジェネリック(後発医薬品)大手「日医工」(富山市)に対し、厚生労働省や県などは24日、医薬品医療機器法に基づき同社の富山第一工場(同県滑川市)を立ち入り調査した。販売停止期間が28日に終了するのを前に、品質管理が適切か確認するのが狙いとみられる。
 立ち入り調査は、薬の安全性などの審査を担う「医薬品医療機器総合機構」と共に実施。25日まで2日間の予定。(2021/03/24-09:44)

2021.03.24 09:44Nation

Nichi-Iko Plant Raided Over Illegal Generic Drug Production


Japanese authorities raided a plant of Nichi-Iko Pharmaceutical Co. in the city of Namerikawa, Toyama Prefecture, central Japan, on Wednesday over the firm's suspected illegal production of generic drugs.
   Earlier this month, the Toyama prefectural government ordered the major maker of generic drugs to suspend production for 32 days and sales for 24 days over the allegations that it has made drugs using methods that are not authorized by the central government.
   The two-day on-site inspection by the health ministry and the prefectural government through Thursday, carried out under the pharmaceuticals and medical devices law, is apparently aimed at checking Nichi-Iko's product quality management before the expiration of the production suspension order on Sunday.
   The state-affiliated Pharmaceuticals and Medical Devices Agency, which undertakes drug safety reviews, also joined the raid. Nichi-Iko is based in the city of Toyama, the capital of the prefecture.
   According to the local government, the Namerikawa plant has been engaged in illegal practices, such as crushing tablets that failed in quality tests for reuse, for about 10 years.

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