金融界6月13日消息，据CDE官网沟通交流公示，于6月13日收到北京科兴生物制品有限公司申请的“II类会议”，当前状态“处理中”。
根据《药物研发与技术审评沟通交流管理办法》（2020年第48号通告），沟通交流会议分为Ⅰ类、Ⅱ类和Ⅲ类会议，就关键阶段重大问题进行沟通交流。Ⅱ类会议一般安排在申请后60日内召开，系指为药物在研发关键阶段而召开的会议，主要包括下列情形：新药临床试验申请前会议、药物Ⅱ期临床试验结束/Ⅲ期临床试验启动前会议、新药上市许可申请前会议、风险评估和控制会议。
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- 北京科兴生物制品有限公司申请II类会议
北京科兴生物制品有限公司申请II类会议
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This page is machine-translated. Futubull tries to improve but does not guarantee the accuracy and reliability of the translation, and will not be liable for any loss or damage caused by any inaccuracy or omission of the translation.