10月11日,NMPA下发43条不带药品批号的“通知件”,意味着多款药品上市失败。其中,创新药方面,复星医药自研的1类肺癌新药丁二酸复瑞替尼胶囊、强生代理的尼古丁口腔喷雾剂等重磅产品未通过审批;仿制药方面,此前深陷原研撤市风波的奥贝胆酸仿制全军覆没,磷霉素氨丁三醇颗粒也第六次未能获批。基于近期通知件数量增加,业内猜测CDE审核趋严,且2023年以来未通过审批的新药比例最高。不予批准的原因多样,新药...
Source Link10月11日,NMPA下发43条不带药品批号的“通知件”,意味着多款药品上市失败。其中,创新药方面,复星医药自研的1类肺癌新药丁二酸复瑞替尼胶囊、强生代理的尼古丁口腔喷雾剂等重磅产品未通过审批;仿制药方面,此前深陷原研撤市风波的奥贝胆酸仿制全军覆没,磷霉素氨丁三醇颗粒也第六次未能获批。基于近期通知件数量增加,业内猜测CDE审核趋严,且2023年以来未通过审批的新药比例最高。不予批准的原因多样,新药...
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