Status and strategy of 3Rs principle application in quality control of biological products
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动物试验一直是包括疫苗在内的生物制品检验放行的重要组成部分.近年来,通过检验采用动物法作为每批产品放行的安全性指标,人们对动物试验的检测意义、要求、方式、操作等各方面均提出了质疑.动物替代(Replace-ment)、减少(Reduction)和优化(Refinement)(简称3Rs)原则自从提出后,越来越受到重视.本文结合我国生物制品监管现状,对3Rs原则在多个国家监管体系中的应用现状,以及世界卫生组织(World Health Organization,WHO)全球相关专家对WHO生物制品指导原则中使用动物开展试验的梳理情况作一综述,旨在推进生物制品质量控制和批放行检测中3Rs原则的实施,以期为我国监管机构、制药行业修订相关内容提供参考.
Animal testing has always been an important part of the inspection and release of biological products including vaccines.In recent years,people have questioned the significance,requirements,methods and operations of animal testing by using animal method as the safety index of each batch of products.The principles of Replacement,Reduction and Refine-ment(3Rs for short)have been paid more and more attention since they were put forward.Based on the current situation of biological products supervision in China,this paper summarizes the application status of 3Rs principle in many national supervision systems,and the combing situation of using animals for testing in World Health Organization(WHO)guidelines on biological products by relevant experts in the world,aiming at promoting the implementation of 3Rs principle in quality control and batch release testing of biological products,and providing a reference for regulatory agencies and pharmaceutical industry to revise relevant contents in China.
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NSTL
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