歐美國家都很重視藥品說明書中的兒科資料，近年來相繼發(fā)布了一些法規(guī)和指導(dǎo)原則。詳細(xì)介紹歐洲藥品管理局（EMA）對藥品說明書中兒科資料的要求，期待引起相關(guān)部門的重視。建議我國藥品上市許可持有人參考EMA和美國食品藥品管理局（FDA）的有關(guān)要求，豐富說明書中兒科信息；同時建議監(jiān)管機(jī)構(gòu)重視起來，并對這些內(nèi)容加強(qiáng)管理，從而確保兒科用藥的安全有效。

Both Europe and the United States attach great importance to the paediatric information in Labling. In recent years, some relevant regulations and guidelines have been issued. This paper introduces in detail the requirements of EMA for pediatric information in SmPC, and looks forward to arousing the attention of our country. It is suggested that the drug marketing license holders in China refer to the requirements of EMA and FDA, to enrich the paediatric information in the labling, and the regulatory authorities pay attention to it, and strengthen the management in order to ensure the safety and effectiveness of pediatric medication.