我国疫苗质量标准的回顾与现状分析

目的 分析研究我国疫苗质量标准现状以及与国外相关技术法规的差异,探索进一步提高和完善我国疫苗质量标准的途径.方法 将《美国药典》(USP)、《欧洲药典》(EUP)和世界卫生组织技术报告(WHO TRS),与《中国生物制品规程》、《中国药典》三部收载的疫苗品种质量标准进行比对.结果与结论 应进一步加深生产企业对疫苗国家标准的理解,找出与国际先进标准的差距,推动我国疫苗生产企业不断优化生产工艺,提高产品质量.

Review and Assessment of Vaccine Quality Standards in China

Objective To review and assess vaccine quality standards in China and reveal the discrepancy between the standards and those of relevant international technology and laws,thus exploring the means to improve vaccine quality standards in China.Methods The vaccine quality standards in Chinese Biological Product Regulations and Chinese Pharmacopoeia(ChP) were compared with those in United States Pharmacopoeia(USP),WHO Technical Report Serials(TRS) and European pharmacopoeias(EUP).Results and Conclusion We should help vaccine manufactures in China further understand national standards for vaccines,explore the gap between their products and international standards and improve their production technology and product quality.