Study Of The Risk Of Drug Quality Regulation

In recent years, the pharmaceutical market globalization lead up a high number of the drug quality risk incidents, in the meantime,drug supervision is influence by it. Whether the drug quality risk regulation is successful depends on the foundation and carrying out effectively of the system.Only the effective risk regulation will guide the society to a correct development and guarantee the safe medication use of the public,and will make our pharmaceuticals industry for a vigorous development.This thesis studied the problem of how to regulate our drug quality risk reasonably and effectively,to look for a economy theory basis for our development of pharmaceuticals industry and the safe medication use, guiding the practice based on the Social regulation theory and Economic Regulation theory.This thesis used the methods such as literature research, comparative analysis and economics Research,choosed the Total risk management theory,the incentive regulation theory,Optimal deterrence theory of Economics of Law and Social regulation theory, analyzed our typical drug quality risk incidents and the source of the problem, integrated our drug quality risk regulation situation, taked example by experience of drug risk regulation in the Europe and America, structured a model of drug quality risk regulation which fits to our national conditions,then gave a proposal from Social regulation and Economic regulation, guarantee the safe medication use of the public.This research considered that the main risk source of our typical drug quality risk incidents are manufacture and circulation field;then analysis our drug quality risk regulation situation problem and their reason;the Social regulation have problems of information communication defect,inspection part is wea,the specialized guidance is lacking, the Economic regulation have problems of a weak ability of sanctions.Also researched the relevant measure about drug risk regulation of the Europe and America, compared it with ours, refined the disparities.Then on the basis of foregoing research, structured a model of drug quality risk regulation from Social regulation and Economic regulation, gave a conformable proposal,such as take a flexible information communication,formulate a specialized guidance,take a low strength incentives to stimulate industries produce acceptable quality drug,increase the Illegal cost,to reach a equilibrium between the drug quality risk and social net benefits. The innovations contain:1,Apply the risk management theory to the drug quality risk regulation,on the basis of COSO toal risk management framework, on condition that the superviser aim at the target of drug quality risk regulation,carrying out the drug quality risk regulation through the Social regulation and Economic regulation;study the quality regulation on the experience goods regulation model,apply it to the drug quality, come to a conclusion that the government should take a low strength incentives to regulate drug quality, to stimulate industries produce acceptable quality drug.Then gave an appropriate proposal. In order to make the government a major proportion in the enterprise's cost,the thesis adopt aging facilities depreciation incentive,reputation incentive,price and taxation incentive, reduce the crowding-out burden,to encourage industries produce the acceptable quality drug.2,The pre-existing researches suggest to increase the penalize mostly,this thesis apply the optimal effect model of Economics of Law to the adulterated drug activities, suggest that we should raise the probability of being caught and increase the penalty amount.The probability of being caught is an important factor of so many counterfeit drug activities.3,The thesis regard the drug quality risk as a whole,it combine the problem and source in our drug quality risk regulation, structured a model of drug quality risk regulation from Social regulation and Economic regulation,and gave proposals about the two sides, made up for a deficiency about the informed research, expanded the research method,bring about an innovation.The drug quality risk regulation is closely related to the personal factors,it will be reduced through an equitable and effective supervision institution. The drug quality risk regulation is a significant system we need,and also a necessary measure about encouraging the Pharmaceutical Industry healthy development,guaranteeing the safe medication use.But because of the risk is hard to show by the exact data,so it's difficult to prove the influence about the drug quality risk. Moreover,in the discussing on the punishment of adulterated drug activities, it is refer to the administrative law,criminal law,civil law,jurisprudence and so on,since this research is weak in the law,some written languages and analyzations are unprofessionell,the study about the law is further investigation.