我国保健食品不予注册现状调查及启示
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The current status of disapproval of health foods in China and its enlightenment
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    目的分析我国保健食品行政许可中不予注册原因,为审批、管理提供支持,为保健食品注册申请提供参考。方法查阅保健食品注册审评管理系统及相关数据,统计分析2004—2010年期间在国家食品药品监督管理局(SFDA)申请注册保健食品的年不批准率、不予注册的各类原因以及变化特点。结果近年来保健食品的不批准率维持在较高水平,约占新申请注册产品的20%。其中以申报资料的真实性问题、配方与工艺的合理性问题,产品质量问题以及各项试验的规范性方面问题较为突出,占到了不予批准原因的3/4以上。但试验报告不规范所致的不批准比例逐年明显下降。结论不予注册产品所反映出的问题是技术审查工作的重点。对注册申请人的启示:①熟悉掌握保健食品相关法规和技术审评规定及动态。②认真做好研发,开发出高科技含量、质量可靠的产品。③如实提供申报资料,保证申报资料质量。

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    Objective To Investigate the current status and the reasons of disapproval of health foods in China,to provide support and guidance for registration.Method Through the Health Food Registration Management System and related statistical data analysis,the rate of disapproval and the distribution of its reasons in 2004-2010 was studied.Results In recent years the disapproval rate of health food remained at a high level,accounting for 20% of all applications.The common reasons are: the authenticity of registration data,the irrationality of formula and technology,product quality problems,and the lack of normative tests,etc.,which accounted for 3/4 of all disapproval reasons.But the proportion of disapproval caused by the informal tests and reports has decreased significantly.Conclusions The problems reflected by the disapproval of products are the focus of technical reviews.The applicants should be familiar with relevant laws,regulations of technical evaluation for health food,especially the new information released by SFDA.On this basis,research and development input should be expanded for product with high technical content and good quality.The materials submitted by applicants should be completed and all application information must be real and correct.

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周素娟,杨飞,白鸿.我国保健食品不予注册现状调查及启示[J].中国食品卫生杂志,2012,24(4):345-347.

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