欧洲药品管理局（EMA）于2022年5月发布了“治疗细菌性感染药物评价指导原则”及其对儿科特殊临床数据要求的补编，旨在指导治疗儿科感染性疾病的抗菌药的临床开发方案的设计。该补编阐明了对儿科治疗细菌性感染药物临床研究的特殊要求，说明了为达到全身效应的全身给药和为达到局部效应的局部或口服给药的设计要点和在少数需要单独儿科人群疗效研究的具体疾病的研究设计要点，特别说明了对药动学研究和疗效研究患者选择的要求。还详细说明了可在年龄亚群间外推和不能外推疗效的感染性疾病。另外还说明了其安全性研究应考虑的问题。而我国还没有类似的指导文件。详细介绍该补编主要内容，希望对中国儿童用抗菌药的临床研发有直接帮助，并对目前促进儿童用药研发创新的举措有益。

The European Medicines Agency (EMA) issued the "guideline on the evaluation of medicinal products indicated for treatment of bacterial infections" and its addendum to the paediatric-specific clinical data requirements in May 2022.The purpose of this addendum is to guide the design of clinical development programmes of antibacterial agents for the treatment of pediatric infectious diseases. This addendum clarifies the special requirements for clinical research of pediatric drugs for the treatment of bacterial infections. It explains the design points of systemic administration to achieve systemic effects and local or oral administration to achieve local effects and explains the research design points of specific diseases that need to be studied separately in a small number of pediatric populations. In particular, it explains the requirements for the selection of patients for pharmacokinetic research and efficacy research. Infectious diseases that can be extrapolated between age subgroups and that cannot be extrapolated are also described in detail. In addition, it also explains the problems that should be considered in its safety research. There is no similar guideline document in China.This addendum is introduced in detail, hoping to be of direct help to the clinical research and development of antibacterial drugs for children in China. The main content of the addendum is introduced in detail, hoping to be beneficial to the current measures to promote the R & D of antimicrobial drugs and innovation of children's medication in China.

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