我國(guó)目前在兒童用藥監(jiān)管中面臨的主要問(wèn)題與美國(guó)兒童用藥監(jiān)管發(fā)展歷程有類似之處，分析美國(guó)兒童用藥監(jiān)管法規(guī)的發(fā)展歷史及現(xiàn)狀，可為我國(guó)完善兒童用藥監(jiān)管政策及相關(guān)法規(guī)提供參考。為解決“治療孤兒”問(wèn)題，促進(jìn)兒科臨床研究，豐富藥品說(shuō)明書中的兒童用藥信息，美國(guó)經(jīng)過(guò)幾十年的探索，逐步建立了“經(jīng)濟(jì)激勵(lì)”與“行政強(qiáng)制”相結(jié)合的政策體系。基于美國(guó)兒童用藥的先進(jìn)監(jiān)管經(jīng)驗(yàn)及現(xiàn)階段我國(guó)兒童用藥監(jiān)管面臨的問(wèn)題，建議監(jiān)管當(dāng)局首先在兒童用藥監(jiān)管制度中引入強(qiáng)制條款，并為兒童用藥研發(fā)提供強(qiáng)有力的經(jīng)濟(jì)激勵(lì)措施。在此基礎(chǔ)上引入類似兒科研究計(jì)劃之類的監(jiān)管工具，并加強(qiáng)監(jiān)管資源的投入。

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.

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