| 国内外疫苗使用说明书规范的比较和探讨 |
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| 引用本文： | 马雷钧. 国内外疫苗使用说明书规范的比较和探讨[J]. 国际生物制品学杂志, 2011, 34(5): 246-251. DOI: 10.3760/cma.j.issn.1673-4211.2011.05.005 |
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| 作者姓名： | 马雷钧 |
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| 作者单位： | 200051 上海生物制品研究所质量检定室 |
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| 摘 要： | 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。
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| 关 键 词： | 疫苗使用说明书 内容 格式 规范化 |
Comparison and discussion of domestic and overseas vaccine package insert criteria |
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| MA Lei-jun. Comparison and discussion of domestic and overseas vaccine package insert criteria[J]. International Journal of Biologicals, 2011, 34(5): 246-251. DOI: 10.3760/cma.j.issn.1673-4211.2011.05.005 |
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| Authors: | MA Lei-jun |
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| Affiliation: | Department of Quality Control, Shanghai Institute of Biological Products, Shanghai 200051, China |
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| Abstract: | 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. |
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| Keywords: | Vaccine package insert Content Format Standardization |
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