基于监管视角的药品生产企业分级监管模型构建

目的：建立药品生产企业分级分类监管模型，为建立适合我国药品生产监管实际的分级监管策略提供方法借鉴。方法：依据分类管理理论，以企业风险水平、企业监管记录和监管频率分析研究为基础，对药品生产企业分级监管模型及其参数进行建立和优化。结果与结论：针对药品生产企业的监管需求与药监部门监管能力之间不相适应的矛盾日益突出等问题，通过分级模型的建立和优化，实现了监管能力和监管需求的良好匹配。

Establishement of a Hierarchical Supervision Model for Pharmaceutical Manufacturing Enterprises Based on Regulatory Perspective

Objective: To establish a hierarchical classification supervision model for pharmaceutical manufacturing enterprises, and to provide references for establishing a hierarchical supervision strategy suitable for the drug production supervision in China. Methods: The hierarchical supervision model and its parameters of pharmaceutical manufacturing enterprises were established and optimized based on the classification management theory and the analysis of risk level of enterprises, supervision records and frequencies. Results and Conclusion: In response to the increasing prominent contradiction between the regulatory needs of pharmaceutical manufacturers and the regulatory capacity of drug supervision departments, a good match between regulatory capacity and its needs has been achieved upon the establishment and optimization of a hierarchical model.