基于免疫理论的仿制药质量安全预警系统构建研究

Study on the Construction of Quality Safety Early Warning System for Generic Drugs based on Immune Theory

目的:构建基于免疫理论的仿制药质量安全预警系统,提高仿制药质量安全。方法:结合药品供应链理论、药物警戒理论及专家咨询法,确定仿制药质量安全预警系统指标体系及权重。结果:仿制药质量安全“抗原”预警子系统包含6个一级指标、23个二级指标,一级指标生产环节预警功能、二级指标药企药品质量信誉指数的权重最高;仿制药质量安全预警“抗体”应对子系统包含4个一级指标、16个二级指标,一级指标政府免疫功能、二级指标搭建多方参与的质监直报系统的权重最高。结论:仿制药生产环节是质量安全的最大隐患,政府免疫功能是仿制药质量安全的最大保障,应充分发挥政府在仿制药监管中的重要作用,建立现代药品供应链质量管理体系,鼓励公众监督,全力保障人民健康。

Objective To construct a quality safety early warning system for generic drugs based on immunization theory,and to improve the quality safety of generic drugs.Methods Combined with drug supply chain theory,pharmacovigilance theory and expert consultation method,the indicator system and weights of quality safety early warning system for generic drugs were determined.Results The quality safety"antigen"early warning subsystem for generic drugs contained 6 first-level indicators and 23 second-level indicators.The production link early warning function in the first-level indicators and the pharmaceutical enterprises'drug quality reputation index in the second-level indicators had the highest weight.The quality safety"antibody"response early warning subsystem for generic drugs contained 4 first-level indicators and 16 second-level indicators.The government's immune function in the first-level indicators and the establishment of a multi-party quality supervision reporting system in the second-level indicators had the highest weight.Conclusion The production process of generic drugs is the biggest hidden danger to quality safety,and the government's immune function is the greatest guarantee for the quality safety of generic drugs.It is necessary to give full play to the important role of the government in the supervision of generic drugs,establish a modern quality management system for the drug supply chain,and encourage the public to supervise,so as to fully protect the health of the people.