[关键词]
[摘要]
欧美都很重视药品说明书中的儿科资料,近年来相继发布了一些相关法规和指导原则。介绍美国食品药品管理局(FDA)对人用处方药和生物制品说明书中儿科资料的要求,期待引起相关部门的重视。建议我国药品上市许可持有人参考FDA对人用处方药和生物制品说明书中儿科资料的要求,丰富药品说明书中儿科信息,同时建议监管机构重视该问题并加强管理,从而确保儿科用药的安全有效。
[Key word]
[Abstract]
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.
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