欧盟儿科药品管理条例系统解析  

System Analysis of Pediatric Regulation in the European Union

作　　者：李秀丽 李丹[1] 瞿礼萍[1] 张廷模[1] 张定堃[1] 王世宇[1] LI Xiuli;LI Dan;QU Liping;ZHANG Tingmo;ZHANG Dingkun;WANG Shiyu(School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]成都中医药大学药学院,成都611137

出　　处：《中国药学杂志》2024年第12期1165-1170,共6页Chinese Pharmaceutical Journal

基　　金：国家社会科学基金青年项目资助(18CGJ036);成都中医药大学“杏林学者”学科人才科研提升计划传承创新专项资助(CCYB2022008);四川省天府青城计划天府科技菁英项目资助(川青城第1341号)。

摘　　要：目的系统剖析欧盟儿科药品管理条例的核心内容,揭示欧盟儿科药品监管特点。方法采用文献研究法分析欧盟儿科药品管理条例、有关指导文件及国内外文献情况。结果欧盟设置儿科药品委员会专门负责儿科药品监管相关事宜,并围绕强制义务要求、奖励与激励措施、其他促进儿科药品研究的措施、信息透明措施4大核心内容进行系统设计,具有强制与激励相结合、多措并举确保有效实施和贯穿药品全生命周期的特点。结论欧盟重视儿科药品监管专业队伍建设,注重强制与激励并行,强调药品全生命周期和动态调整理念,为促进儿科药品开发与可获得性提供了全方位保障,值得我国借鉴。OBJECTIVE To analyze the key contents of paediatric regulation in the European Union(EU)and identify the characteristics of the European regulation for paediatric medicines.METHODS A literature review was conducted to analyze the EU paediatric regulation,relevant guidance documents and published literatures.RESULTS The EU has established the paediatric medicines committee,which is specifically responsible for issues related to the regulation of paediatric medicines.Moreover,the EU has systematically designed the regulation around four aspects including obligations,rewards and incentives,other initiatives for paediatric medicines research and information and transparency measures.CONCLUSION The EU attaches great importance to building a professional team for the regulation of paediatric medicines,focusing on both mandatory and incentives,and emphasizing the concepts of the whole life cycle of medicines and dynamic adjustments,which provide a comprehensive guarantee for promoting the development and availability of paediatric medicines.It deserves to be studied and learned from.

关 键 词：儿科药品 监管 强制义务 奖励 激励 全生命周期 

分 类 号：R95[医药卫生—药学]