《化学药品和治疗用生物制品说明书中儿童用药相关信息撰写的技术指导原则(试行)》起草背景及要点内容  

Background and key elements of “Guidance for Writing Pediatric Information in Labelings of Chemical Drugs and Biological Products (Trial)”

作　　者：耿莹 张豪 王丽卿 梁宇光 王小川 孙艳喆 李强 王晓玲[2] 杨志敏 GENG Ying;ZHANG Hao;WANG Li-qing;LIANG Yu-guang;WANG Xiao-chuan;SUN Yan-zhe;LI Qiang;WANG Xiao-ling;YANG Zhi-min(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Department of Pharmacy,Beijing Children's Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]首都医科大学附属北京儿童医院药学部,北京100045

出　　处：《中国新药杂志》2022年第4期323-328,共6页Chinese Journal of New Drugs

摘　　要：近年来,随着系列改革政策的出台,儿童用药的研发越发受到重视,儿童用药的科学监管力度也越发增强,但是药品说明书中儿童用药信息的缺失或不完善问题依然突出,尚缺乏有效措施予以规范。本文介绍了我国目前存在的药品说明书中儿童用药信息缺失或不完善问题,梳理了美国、欧洲和我国的法规制定历程,介绍了《化学药品和治疗用生物制品说明书中儿童用药相关信息撰写的技术指导原则(试行)》的起草背景,最后详细介绍了该指导原则及要点内容。In recent years, with the introduction of a series of reform policies, the research and development of pediatric drugs has been paid more and more attention, and the scientific supervision of children’s medication has been strengthened. However, the lack or imperfection of pediatric information in the drug labelings is still prominent, and there is still a lack of effective measures to regulate it. This paper introduces the lack or imperfection of pediatric information in drug instructions in China, combs the formulation process of laws and regulations in the United States, Europe and China, forms the drafting background of the “Guidance for Writing Pediatric Information in Iabeling of Chemical Drugs and Biological Products(Trial)”, and finally introduces the guiding principles and key points in detail.

关 键 词：药品说明书 儿童用药 指导原则 

分 类 号：R95[医药卫生—药学]