10月27日—11月2日医药行业动态如下:政策及药监方面,国家药监局统一修订右旋糖酐铁注射液说明书,涉及不良反应等项;公布新版药品生产许可证和放射性药品生产许可证样式,2026年1月1日起启用;就《药品质量抽查检验管理办法(征求意见稿)》征求意见;将芦沃美替尼片纳入儿童抗肿瘤药物研发鼓励试点计划;公示4个仿制药一致性评价任务。产品研发上市上,国家药监局发布4期药品批准证明文件送达信息,CDE承办...
Source Link10月27日—11月2日医药行业动态如下:政策及药监方面,国家药监局统一修订右旋糖酐铁注射液说明书,涉及不良反应等项;公布新版药品生产许可证和放射性药品生产许可证样式,2026年1月1日起启用;就《药品质量抽查检验管理办法(征求意见稿)》征求意见;将芦沃美替尼片纳入儿童抗肿瘤药物研发鼓励试点计划;公示4个仿制药一致性评价任务。产品研发上市上,国家药监局发布4期药品批准证明文件送达信息,CDE承办...
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