国内外疫苗使用说明书规范的比较和探讨

Comparison and discussion of domestic and overseas vaccine package insert criteria

目的了解国外疫苗使用说明书的规范要求和现行国外说明书的优点和经验，为完善规范我国的疫苗说明书提供参考。方法对美国、欧盟和我国疫苗使用说明书的制定规范、格式和主要内容进行比较。结果美国、欧盟和我国疫苗使用说明书的格式较为接近，而在制定规范以及药理学、毒理学、临床试验和不良反应等主要内容方面存在较大差异。结论我国应该借鉴国外药品监管当局对于说明书的规范要求，完善说明书的制定规范，细化说明书的信息，扩大疫苗信息知晓度，以保障疫苗的安全性和有效性。

Objective To learn overseas vaccine package insert criteria and advantages and experience of current package inserts, and to enhance standardization of package inserts in our country. Methods The criteria, formats and main contents of the vaccine package inserts in the USA and European Union （EU） were compared with those in China. Results The formats in the USA, EU and China were similar, but the criteria and main contents, including pharmacology, toxicology, clinical trials, and adverse reactions, were different from each other greatly. Conclusions The contents and criteria established by overseas regulatory authorities should be used for reference. The safety and effectiveness of vaccines would be guaranteed by detailing and perfecting package insert criteria and strengthening legislation.