我国仿制药质量关键影响因素分析

目的：研究我国仿制药质量的关键影响因素，为药品监管政策制定和实施提出合理建议。方法：采用问卷调查和探索性因子分析法研究影响仿制药质量的不同主体因素和生产企业内部因素。结果：进行了两轮问卷调查，分别发放了110和170份问卷，有效回收99和159份。研究结果显示：影响仿制药质量的因素按重要性依次为企业＞监管＞激励政策＞药品使用＞配套措施，企业内部影响因素的重要性依次为关键技术＞实施操作＞风险控制＞仪器设备＞原辅料质量。结论：仿制药质量受到企业内部因素和监管因素、产业环境因素、使用因素等多种外部因素的影响；生产企业内部因素是影响药品质量的决定因素， 其中又以企业的关键生产技术最为重要。

Study of Key Factors Influencing the Quality of Generic Drug in China

Objective: To study the key influencing factors of generic drug quality in China and put forward reasonable suggestions for the formulation and implementation of drug regulatory policy. Methods: Questionnaire surveys were conducted and the data collected were assessed using exploratory factor analysis (EFA). Results: Totally 110 and 170 questionnaires were issued separately and 99 and 159 were returned, respectively. Results showed that manufacturers, regulatory authorities, industry environment, drug use and policy support were listed in a descending order regarding the impact severity on the quality of generic drugs, while the order with internal factors were key technologies, operation, risk management, equipment and quality control of incoming materials. Conclusion: Generic drug quality was influenced by factors related with manufacturers, industrial environment, and clinical use, etc. Of all the factors assessed, manufacturer was the most crucial influencing factor on drug quality.