[关键词]
[摘要]
美国食品药品管理局(FDA)于2017年8月发布了《药品说明中儿童安全包装描述的指导原则》,主要介绍对药品说明书、纸盒标识和容器标签中儿童安全包装描述的要求。而目前在我国尚无类似的指导原则,详细介绍该指导原则的主要内容,期待引起药品生产企业的重视与参考以及对我国药监部门有所启示。
[Key word]
[Abstract]
FDA issued the Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry in August 2017, and mainly introduces the requirements for Child-Resistant Packaging Statements in Labeling, and on carton labeling and container labels. However, there is no similar guidance in our country. This paper introduces the guidance in detail, and expects to arise the attention and provide reference of pharmaceutical companies as well as the enlightenment to the administration of drug administration in China.
[中图分类号]
[基金项目]