歐美都很重視藥品說(shuō)明書中的兒科資料，近年來(lái)相繼發(fā)布了一些相關(guān)法規(guī)和指導(dǎo)原則。介紹美國(guó)食品藥品管理局（FDA）對(duì)人用處方藥和生物制品說(shuō)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FDA對(duì)人用處方藥和生物制品說(shuō)明書中兒科資料的要求，豐富藥品說(shuō)明書中兒科信息，同時(shí)建議監(jiān)管機(jī)構(gòu)重視該問(wèn)題并加強(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 pediatric information in Labeling. In recent years, some relevant regulations and guidelines have been issued. This paper introduces in detail the requirements of FDA for pediatric information in Human Prescription Drug and Biological Product Labeling, 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 FDA, to enrich the pediatric information in the labeling, and that the regulatory authorities should not ignore this, but strengthen the management, in order to ensure the safety and effectiveness of pediatric medication.