中国药品审评规制体系的历史演变及未来走向

发布时间：2018-03-15 05:32

本文选题：制度变迁　切入点：路径依赖　出处：《公共管理学报》2017年02期 　论文类型：期刊论文

【摘要】：本文应用历史制度主义的分析方式,同时辅以问卷调查和面对面访谈的研究方法,对中国药品审评规制体系的历史脉络和现状进行了梳理和研究。结果发现,囿于历史与结构的锁定,中国药品审评的模式、原则、体系等存在着不同程度的路径依赖现象,导致了药品审评供给与企业实际需求的不平衡。解决这一问题应进一步推进药品审评审批制度的深入变革,实现中国药品审评规制体系在使命定位、治理结构、运行机制三方面的重塑。具体而言,在审评理念上,应树立以"临床价值为核心"的创新理念;在治理结构上,一方面尽快解决制度供给结构匮乏与功能错位的问题,一方面以"专业化"和"职业化"为重点进行审评队伍建设,推动国家药品审评中心从适度分立型机构走向独立咨询型机构;在运行机制上,不仅局限于内部运行机制的建设,更应该将药品准入规制置于药品规制全链条的环境下考量,以内外机制的共建助推审评工作的科学化和专业化。
[Abstract]:In this paper, the historical context and current situation of China's drug review and regulation system are combed and studied by means of historical institutionalism, combined with questionnaires and face-to-face interviews. Due to the locking of history and structure, there exists different degree of path dependence in the mode, principle and system of drug review in China. This has led to the imbalance between the supply of drug review and the actual demand of enterprises. To solve this problem, we should further promote the in-depth reform of the drug review and approval system, and realize the mission orientation and governance structure of China's drug review and regulation system. On the one hand, it is necessary to set up the innovative idea of "clinical value as the core", on the one hand, to solve the problems of the shortage of institutional supply structure and the dislocation of function as soon as possible in the governance structure. On the one hand, focusing on "specialization" and "professionalization" to build the review team, the National Drug Review Center should be promoted from moderately separate institutions to independent consulting institutions, and the operational mechanism should not be limited to the construction of internal operational mechanisms. Moreover, the regulation of drug access should be considered under the environment of the whole chain of drug regulation, and the scientific and professional work should be promoted by the co-construction of internal and external mechanisms.
【作者单位】：中共辽宁省委党校公共管理教研部;清华大学公共管理学院;
【分类号】：R95

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