歐洲藥品管理局（EMA）于2022年5月發(fā)布了“治療細(xì)菌性感染藥物評價指導(dǎo)原則”及其對兒科特殊臨床數(shù)據(jù)要求的補(bǔ)編，旨在指導(dǎo)治療兒科感染性疾病的抗菌藥的臨床開發(fā)方案的設(shè)計(jì)。該補(bǔ)編闡明了對兒科治療細(xì)菌性感染藥物臨床研究的特殊要求，說明了為達(dá)到全身效應(yīng)的全身給藥和為達(dá)到局部效應(yīng)的局部或口服給藥的設(shè)計(jì)要點(diǎn)和在少數(shù)需要單獨(dú)兒科人群療效研究的具體疾病的研究設(shè)計(jì)要點(diǎn)，特別說明了對藥動學(xué)研究和療效研究患者選擇的要求。還詳細(xì)說明了可在年齡亞群間外推和不能外推療效的感染性疾病。另外還說明了其安全性研究應(yīng)考慮的問題。而我國還沒有類似的指導(dǎo)文件。詳細(xì)介紹該補(bǔ)編主要內(nèi)容，希望對中國兒童用抗菌藥的臨床研發(fā)有直接幫助，并對目前促進(jìn)兒童用藥研發(fā)創(chuàng)新的舉措有益。

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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