【摘要】 药品监管质量管理规范(GRP)建设，是增强药品监管部门执行力公信力、提升药品全生命周期管理能力、降低药品技术性贸易壁垒和推动药品监管职能转变的制度基础。基于我国GRP实施现状、国际组织互认协议和部分地方政府监管体系等比较分析，本文对GRP体系的分类与原则、建设内容和制度框架进行开拓性研究，提出GRP建设的国际互认协议、协调层级、地方制度创新、市场监管卫生健康制度移植和数字化流程再造等原则，以及基于组织协调、工作流程、专业知识的GRP建设霍尔三维空间结构，GRP规范/指南编制的综合评价方案。更多还原

【Abstract】 The construction of Good Regulatory Practice (GRP) is the institutional basis for enhancing the executive power and credibility of government,improving the ability of drug life cycle management,reducing drug technical trade barriers,and promoting the transformation of drug regulatory function.Based on the comparative analysis of implementation status of GRP,mutual recognition agreements of international organizations,and supervision systems from several countries,this paper conducted the pioneering research on the classification and principle of GRP system,construction content,and construction framework,and proposed the principles of GRP construction,e.g.the international mutual recognition agreement,government coordination level,local regulatory innovation,system transplantation about market administration and health administration,and the digital process reengineering.Especially this paper studied the Three-dimensional Space Structure of GRP construction based on the organizational coordination,work flow,and the professional knowledge,and put forward the comprehensive evaluation solution for the formation of GRP standard/guideline.更多还原