美国儿童用药监管的立法沿革及对我国的启示

我国目前在儿童用药监管中面临的主要问题与美国儿童用药监管发展历程有类似之处,分析美国儿童用药监管法规的发展历史及现状,可为我国完善儿童用药监管政策及相关法规提供参考。为解决“治疗孤儿”问题,促进儿科临床研究,丰富药品说明书中的儿童用药信息,美国经过几十年的探索,逐步建立了“经济激励”与“行政强制”相结合的政策体系。基于美国儿童用药的先进监管经验及现阶段我国儿童用药监管面临的问题,建议监管当局首先在儿童用药监管制度中引入强制条款,并为儿童用药研发提供强有力的经济激励措施。在此基础上引入类似儿科研究计划之类的监管工具,并加强监管资源的投入。

Legislative evolution of pediatric drug regulation in United States and its implications for China

There are similarities between the regulatory history of pediatric medicines in the United States and dilemma of the pediatric medicines regulation faced by China at present. Analyze the development history and current situation of pediatric medicines administration regulations in the United States can provide reference for improving pediatric drug administration policies and related regulations in China. In order to solve the problem of "Therapeutic Orphans", promote pediatric clinical studies, and ensure that drug labeling contain adequate information on pediatric use, the United States has gradually established a policy system that combines "economic incentives" and "mandatory requirement" after decades of exploration. Based on the advanced administration experience of pediatric medicines in the United States and the problems of China''s pediatric mediacines regulation at this stage, it is recommended that, first of all, administration authorities should introduce mandatory requirements to administration system of pediatric medicines, and provide powerful economic incentives for pediatric product development; Secondly, set up regulatory tools similar to pediatric study plan, and strengthen the input of regulatory resourses.