摘要
欧美国家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法规和指导原则。详细介绍欧洲药品管理局(EMA)对药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EMA和美国食品药品管理局(FDA)的有关要求,丰富说明书中儿科信息;同时建议监管机构重视起来,并对这些内容加强管理,从而确保儿科用药的安全有效。
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.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2019年第10期1913-1919,共7页
Drug Evaluation Research
