从药品注册专员的角度看药品审评中心的改革与发展

目的：总结国家食品药品监督管理总局药品审评中心创新探索药品审评质量管理体系的思路及成果，为相关机构提供借鉴。方法：从改革组织机构、完善管理制度、加大公开力度、大胆创新探索、问题与改进完善几个方面，对2011-2012年间药品审评中心的改革与发展状况进行梳理总结，并从药品注册专员的角度进行分析。结果与结论：良好的审评管理体系是保证审评决策质量与效率、公平与公正的关键。药品审评中心与时俱进，实施了调整审评任务、启动单独按序审评、鼓励创新和优化资源配置等一系列改革发展举措，为公众用药安全、有效提供了切实保障；同时其管理和审评制度体系建立的历程和经验也将为监管机构和企业提供借鉴。

Investigation of the Reform and Development of Center for Drug Evaluation from the Perspective of Register

OBJECTIVE： To discuss the thought ant results of innovative exploration for the management system of drug evalu- ation by Center for Drug and Evaluation of SFDA, and to provide reference for related institution. METHODS： The reform and de- velopment of Center for Drug Evaluation during the period of 2011- 2012 were summarized and briefly analyzed from the perspec- tive of a register. It was analyzed from several aspects： reform of the organization, improvement of management system, increase of openning, bold innovation, problems and prospects. RESULTS ＆ CONCLUSIONS： Good management system of evaluation is the key to ensure quality, efficiency, fairness and justice of decision-making. Center for Drug Evaluation keeps up with the times, and carries out a series of reform and development measures, such as adjusting evaluation assigment, strafing individual serial eval- uation, encouraging innovation and optimizing resource allocation. The safe and effective drug use in the public can be guaranteed, and the experience about the establishment of managerrent and evaluation system will provide reference for supervision institution and enterprise.