摘要
目的通过梳理我国儿童用药政策法规,以及临床用药面临问题,为进一步完善儿童用药政策体系提供参考。方法检索相关数据库和我国药品管理相关网站,使用预先设计好的数据提取表收集我国儿童用药政策相关信息,进行归纳、分析和总结。结果研究最终纳入36项我国卫生部门/药品监管出台的有关儿童药物政策法规,儿童药物政策主要从研发生产、注册审评、配备使用、监测评价4个环节提供临床儿童用药保障。截至2021年5月,国家出台关于儿童用药政策中9项涉及研发生产;9项涉及注册审评;14项涉及配备使用;4项涉及监测评价。结论我国儿童药物供应保障政策体系有待进一步完善,应在研发生产、注册审批、配备使用、监管评价等环节制定有效的专项政策和强制措施,保障儿童用药的有效供应,规范临床用药。
Objective By summarizing the policies and regulations of drug use for children in China,as well as the problems in clinical drug use,it provides reference for further improving the policy system of drug use for children.Methods Related databases and websites related to drug management in China were searched,and information related to drug policy for children in China was collected using pre-designed data extraction table,and summarized,analyzed and summarized.Results The study finally included 36 policies and regulations related to children’s drugs issued by China’s health authorities.The children’s drug policy mainly provides clinical child drug security from four aspects:research and development,registration review,allocation and use,and monitoring and evaluation.As of May 2021,9 of the national policies on children’s drug use involve research and production;9 items involve registration review;14 items involve equipment and use;4 items involve monitoring and evaluation.Conclusion The policy system for ensuring the supply of drugs for children in China needs to be further improved.Effective special policies and compulsory measures should be formulated in research and production,registration and approval,allocation and use,supervision and evaluation,so as to ensure the effective supply of drugs for children and standardize rational clinical drug use.
作者
蒋范黎
刘永军
JIANG Fan-Li;LIU Yong-Jun(International Medical Business School of China Pharmaceutical University,Nanjing 210000,China)
出处
《中国药物经济学》
2022年第11期33-37,共5页
China Journal of Pharmaceutical Economics
关键词
儿童用药
供应保障
政策
Children’s drugs
Supply security
Policy
