摘要
儿童药品是基本的民生保障,儿童用药的安全问题则是各国面临的共同挑战。儿童药品剂型和规格缺乏、专用药少、用药安全面临风险等问题在我国长期存在。在加快儿童药品上市的同时,需加强儿童药品全生命周期的风险管理和控制,建立符合儿童特点的药品风险管理体系和保险制度,确保儿童用药安全。
Pediatric drugs provide essential guarantee for children’s welfare,while the safety of pediatric drugs is a common challenge faced by all countries.The lack of dosage forms and specifications for pediatric drugs,lack of pediatric-focused drugs and the safety risks posed by pediatric drug use are long-standing problems in China.In addition to assuring faster access to pediatric drugs,it is necessary to enhance total life cycle risk management and risk control of pediatric drugs and to establish a risk management system and insurance system best suited for children so as to ensure the safety of pediatric drug use.
出处
《中国食品药品监管》
2021年第1期28-34,共7页
China Food & Drug Administration Magazine
基金
重大新药创制科技重大专项“儿童示范性新药临床评价技术平台建设”(2017ZX09304029)
首都卫生管理与政策研究基地2020年度开放性课题“基于儿科人群特点建立药物临床试验风险受益评价体系”(2020JD05)。
关键词
儿童药品
挑战
风险管理
保险制度
用药安全
pediatric drugs
challenge
risk management
insurance system
safety
