歐美國(guó)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(duì)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(guó)藥品上市許可持有人參考EMA和美國(guó)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(shí)建議監(jiān)管機(jī)構(gòu)重視起來，并對(duì)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.