构建江西省药品认证审评中心审评质量管理规范的探讨

Discussion on Constructing the Review Quality Management Standard of Center for Drug Certification and Evaluation of Jiangxi Provence

该文从江西省药品认证审评中心从事的审评任务出发,对前期的药品技术审评存在的问题进行总结归纳。提出解决问题的方法,即建立药品和医疗器械审评质量管理规范,让技术审评有章可循,有规可依,同时也阐述了建立技术审评质量管理规范的现实意义。最后,以江西省药品认证审评中心开展技术审评质量管理规范实践为例,介绍了建立药品和医疗器械审评质量管理规范过程,为其他同类型的政府审评工作情况提供参考依据。

Based on the task of Jiangxi Center for Drug Certification and Evaluation,this paper summarizes the problems of drug technical evaluation in the early stage.The method to solve the problem was to set up the technical evaluation quality management standard,so that the technical evaluation has rules to follow,and also expounds the practical significance of setting up the technical evaluation quality management standard.Finally,taking Jiangxi Center for Drug Certification and Evaluation to carry out technical evaluation and quality management practices as an example,introduces the process of establishing the technical evaluation and quality management standard,and provides reference for other similar cases.