金融界3月5日消息,据CDE官网沟通交流公示,于3月5日收到凯西医药咨询(上海)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。
凯西医药咨询(上海)有限公司,成立于2008年,位于上海市,是一家以从事商务服务业为主的企业。企业注册资本350万人民币,实缴资本350万人民币。
通过天眼查大数据分析,凯西医药咨询(上海)有限公司拥有行政许可15个。
主要股东信息显示,凯西医药咨询(上海)有限公司由CHIESI FARMACEUTICI S.P.A.持股100%。
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