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药品生产企业派驻监督员制度作为借鉴国外的生产监管手段,自2007年初实行至今,已有一年多时间。国家食品药品监督管理局专门发布了《派驻监督员管理暂行规定》,并组织了培训。各省各地市推进的派驻监督工作各具特色。北京市药品监督管理局经济技术开发区分局在实施中不断摸索和完善,初步获得良好的监管效果。然而,派驻监督员制度的产生有其特殊的社会背景和历史条件,由于对制度本身和实施方面的研究和准备不足,使具体的派驻监督工作面临亟待解决、不容回避的现实问题。本文在回顾派驻监督员制度的历史和我国药监部门实施现状的基础上,重点阐述了北京药监开发区分局的收获和启发,同时从宏观的角度对派驻监督工作面临的困境和困惑进行分析,并对该项制度的完善发展提供建议。
The supervisory system for drug production enterprises has been in operation for more than a year since it was implemented in early 2007 as a means of monitoring foreign production. The State Food and Drug Administration released the Interim Provisions on the Management of Surveillance Officers and organized training. Various provinces and cities to promote the work of monitoring the presence of different characteristics. Economic and Technological Development Zone Branch of Beijing Municipal Administration of Drug Administration continued to explore and improve in the implementation of the initial access to good regulatory effect. However, there is a special social background and historical conditions for the establishment of the supervisor system. Due to the lack of research and preparation on the system itself and its implementation, the specific supervisory work is confronted with the immediate problems that must be solved and can not be avoided. On the basis of reviewing the history of the supervisor system and the status quo of the implementation of the drug administration in our country, this article focuses on the harvest and inspiration of the branches of Beijing Drug Administration Development Zone. At the same time, it analyzes the difficulties and confusions confronting the surveillance work from a macro perspective. , And provide suggestions for the perfect development of the system.