[关键词]
[摘要]
为促进新型冠状病毒肺炎(COVID-19)疫苗和治疗药物在欧盟的开发和应用,欧洲药品管理局(EMA)于2020年12月发布了“COVID-19疫苗说明书灵活性问答”,并于2021年3月又发布了“COVID-19治疗药说明书的灵活性”两个文件,表明EMA对COVID-19疫苗和治疗药物的包装说明书和标签的审批采取了不同于常规做法的灵活措施,以加速COVID-19疫苗说明书和标签的审批。其中主要说明具体的简化要求,如可只用英文,而不要求用本国文字;在早期阶段可以省略外包装纸盒内的包装说明书;印刷包装说明书的数量可少于注射次数;在早期阶段标签可省略一些细节等等。中国虽然出台了一系列有关COVID-19疫苗的指导原则,但还没有涉及说明书和标签。介绍EMA的两个文件,以期对我国该方面的工作有所启示,尤其是对供欧盟成员国使用的国产疫苗有直接的参考价值。
[Key word]
[Abstract]
EMA issued the Questions and answers on labelling flexibilities for COVID19 vaccines in December 2020 and the Labelling flexibilities for COVID-19 therapeutics in March 2021 to promote the development and application of COVID-19 vaccines and therapeutics in the EU. The two documents indicate that EMA has adopted flexible measures different from the conventional practice in the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics, so as to accelerate the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics. Among them, it mainly explains the specific simplified requirements, for example, it can only use English instead of national language; in the early stage, it can omit the packaging leaflet in the outer carton; the number of printed packaging leaflets can be less than the number of doses; in the early stage, some details can be omitted from the label, and so on. Although China has issued a series of guidelines on the COVID-19 vaccine, there are no packaging leaflets and labels involved. This paper introduces the two documents of EMA, which will have enlightenment for our work in this field. In particular, it has direct reference value for domestic vaccines used by EU Member States.
[中图分类号]
R951
[基金项目]