Study On Drug Examination And Approval System Of China

In recent years, there have been several fatally serious adverse drug events in China. Especially the events of"Qi Er Yao"and"Xin Fu"cause extremely negative effects, and make the deficiency of Drug Examination and approval system (DEAS) exposed in the public. Since drug safety is closely related to health, it is necessary and important to improve the current DEAS, on the aspects of how to efficiently guarantee drug safety for the public, promote the healthy development of medicine, and advance public trust to the governments. The DEAS of different countries have distinct characteristics because of their dissimilarity of state situation and drug administration development, and these can be seen from the DEAS of various foreign countries. So, I think, Chinese drug administration needs innovation and improvement, on the basis of both using other countries'advanced DEAS for reference and considering Chinese current situation.Drug administration of USA has evolved for about 100 years, and USA has learned experience from it and formed a comparatively mature and complete drug administration system. Now USA has been the largest medical market in the world, and her medical administration system is consistent with the rules of WTO. So, in order to keep up with the trends of globalizing development, China—a new member of WTO—should improve the DEAS by combining advanced experience from drug administration of USA and Chinese current development situation. This article applies the means of comparative study and case analysis, studies drug administration systems of USA, reflects drug legislation and other relative problems of China, and then brings forward government regulation theories about the DEAS of China. Mean while, this article puts forward the policies about how to improve the drug administration, through analyzing Chinese drug approval system, procedure, evaluation substandard, and the problems which exist in practice.Drug Examination and approval is a national administrative license program, and belongs to the areas of departmental administrative laws. So I hope this article could accomplish the application of the principles of administrative laws to the problems of departmental administration laws, and promote the study of national administrative laws, by analyzing the current problems of drug administration.