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湖北医药企业严重违规GMP证书被收回 四家整改后重新发回
2017-08-22 10:43:43 中国青年网
7月27日,湖北省食品药品监督管理局发布公告称,湖北一半天制药有限公司因严重违反《药品生产质量管理规范》(2010年修订),依法收回其《药品GMP证书》,并责令企业整改。经现场检查,该企业现已符合药品GMP要求,依据《药品生产质量管理规范认证管理办法》第三十四条规定,依法发回其《药品GMP证书》。此次发回的证书编号为:HB20140122,发回证书范围为原料药(抗肿瘤药:盐酸吉西他滨)。此前,2016年8月4日,湖北一半天制药有限公司严重违反《药品生产质量管理规范》(2010年修订)规定,依据《药品生产监督管理办法》第五十五条和《药品生产质量管理规范认证管理办法》第三十三条规定,依法收回其《药品GMP证书》。
7月28日,湖北省食品药品监督管理局发布公告称,湖北中佳合成制药股份有限公司严重违反《药品生产质量管理规范》规定,依据《药品生产质量管理规范认证管理办法》第三十三条规定,依法收回其《药品GMP证书》。收回证书编号:HB20150130;收证范围是:原料药(棓丙酯)。
湖北省食品药品监督管理局发布的公告上,并没有披露上述企业“严重违规”生产的时间,以及该期限内生产了多少产品,这些产品是否在市场上流通,也没有公布监管部门对企业“严重违规”情况下生产的产品是如何监管、查处等情况。如果“严重违规”期间生产的产品已经在市场流通使用,涉及多少患者?有关责任该由谁来承担?本网将持续关注。(冀东)
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