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深化医疗器械警戒试点工作推进会在京召开
Xin Lang Cai Jing· 2025-12-30 12:58
格隆汇12月30日|国家药监局12月30日在北京召开深化医疗器械警戒试点工作推进会。会议听取了第一 批试点省份工作汇报,研究部署进一步深化试点工作的具体措施。国家药监局党组成员、副局长徐景和 出席会议并讲话。会议要求,要深入贯彻落实党的二十大和二十届历次全会精神,深刻领会深化医疗器 械警戒试点工作的重要意义;要明确各方责任,落实试点工作任务,强化制度和运行机制建设;要完善 平台和体系,推进"一体两翼"建设,提升警戒能力;要充分利用AI等技术,强化科技赋能,快速识别风 险信号,做好风险处置。 ...
我国儿童用药超90%非儿童专用药,“改良型新药”如何破局
Di Yi Cai Jing· 2025-10-13 12:28
Core Insights - The development of pediatric drugs has become a focal point in the market due to current policies promoting priority reviews and approvals [1] - There is a significant unmet demand for pediatric medications, with only a small percentage of drugs specifically designed for children [2] - The National Medical Products Administration (NMPA) has issued guidelines to encourage the development of modified new drugs for children, emphasizing the importance of protecting the rights of child participants in clinical trials [3][4] Industry Overview - Over 90% of pediatric medications in China are not specifically designed for children, highlighting a critical gap in the pediatric drug supply system [2] - The market for pediatric drugs is expanding, but issues such as drug shortages and lack of evidence-based clinical use remain prevalent [2] Regulatory Developments - The NMPA's recent response outlines the need to encourage the development of modified new drugs for pediatric use, which can include expanding existing adult drugs to children [3] - The guidelines stress that clinical value for pediatric drugs may differ from adult applications, allowing for a broader interpretation of clinical benefits [4] Clinical Trial Considerations - The NMPA emphasizes the importance of minimizing unnecessary repetitive studies in pediatric drug development, advocating for the use of existing research evidence [6] - Ethical considerations are paramount in pediatric clinical trials, with a focus on ensuring the safety of child participants [6][7] Research Methodologies - Real-world studies (RWS) are highlighted as a valuable complement to randomized controlled trials (RCT) in pediatric drug development, especially when ethical challenges arise [8] - The use of adult data extrapolation is acknowledged, but caution is advised as safety data may not fully predict adverse reactions in children [7]
中央纪委国家监委网站发布反腐月报
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-01 04:34
8月1日,中央纪委国家监委网站发布反腐月报。 74人被查,46人被处分 7月,中央纪委国家监委网站受权发布通报—— 74人接受审查调查: 贵州省委常委、毕节市委书记吴胜华接受中央纪委国家监委纪律审查和监察调查; 十三届全国政协教科卫体委员会副主任刘慧接受中央纪委国家监委纪律审查和监察调查; | 贵州省委常委、毕节市委书记吴胜华接受中央纪委国家监委纪律审查和监察调查 | 2025-07-24 | | --- | --- | | 十三届全国政协教科卫体委员会副主任刘慧接受中央纪委国家监委纪律审查和监察调查 | 2025-07-18 | | 陕西省西安市人大常委会党组书记、主任韩松接受中央纪委国家监委纪律审查和监察调查 | 2025-07-14 | | 湖北省政协原党组成员、副主席周先旺接受中央纪委国家监委纪律审查和监察调查 | 2025-07-08 | | 原中国中化集团有限公司党组成员、副总经理冯志斌接受中央纪委国家监委纪律审查和监察调查 | 2025-07-04 | 此外还有:黑龙江省铁路集团有限责任公司原党委书记、董事长赵忠发,上海市浦东新区人民检察院检察长曾国东,四川省巴中市委原书记何平,云南省 昆明市政 ...