The Analysis Of The Factors Of The Drug Qualified Person System Based On Interpretative Structural Modeling (ISM)Method——Focus On The Regulatory Department, The Manufacturers, The Qualified Person

The Chinese government has traditionally paid high attention to the supervision and administration of drug safety. In recent years, along with the rapid development of our economy, society and science and technology, the public demand to health care products has been increasing, the society is paying more attention to the drug safety, and the harm of drug incidents to the society is becoming more and more obvious. Therefore, in order to reinforce the drug safety supervision, and speed up the formulating pace of improving the drug safety supervision system, the China’s drug regulatory department introduced the qualified person system from the EU. In the countries from the EU which have developed pharmaceutical manufacturing industry, the system has been proved effective in practice in the assurance of the drug safety. However, since the implementation of the system in our country, it has not achieved the ideal effect. So far, not much research has been done to address the issue. Therefore, the deep study from multiple angels to the system has theoretical and practical significance to perfect the China’s drug safety supervision system. With the elaboration on the historical position and effect, and its development trend of the qualified person system, using the research methods of systems engineering with system theory in mind, and considering the connections of the drug regulatory department, the drug manufacturer, and the qualified person in the system operation as an organic whole, the paper builds a system model according to the associations of the three system elements. Meanwhile, with the structural model built by using Interpretative Structural Modeling (ISM), the paper analyses the connections of each element in the system. Through the analysis of system structure, we can have a comprehensive and essential understanding of the issue.The results showed that the system model of the drug regulatory department, the drug manufacturers and the qualified person has an eight-level hierarchical structure. Through the analysis of the system structural model, it comes into conclusions that the degree of influence is not different the activites of the drug regulatory department, the drug manufacturers and the qualified person to the drug qualified person system. Deeper problem is on the drug regulatory department; the surface problem is on the qualified person; the potential problem is on the drug manufacturers. Other, judging from the length of the path, the drug regulatory department and the drug manufacturer on binding the qualified person is different.