Research On Chinese Drug Government Regulation

Combining with basic theories of economics and political science, this article focuses on the Chinese drug government regulation and analyzes four problems on drug government regulation mainly from the perspective of public law. The problems are fundamental principle, regulation agency, regulation objective, regulation scope and method, operating mechanism.The preamble: beginning with several typical cases of Chinese drug regulation, it briefly analyzes current status and problems of Chinese drug regulation and points out the practical significance of researching government regulation of drug in China. Then it clarifies the rise of government regulation and its influence on administrative law research. At last, the logical thoughts and the research methods of this article are mentioned.Chapter one: basic theories about drug government regulation.Government regulation can be understood by four aspects, i.e. objective, agency, scope and method. Government regulation of drug is the lawful administration and supervision taken by regulation agency on the whole course of drug research, production, management and use with an aim to rectify market failure , maintain the order of the drug market and ensure the safety of the public. The reasons for drug regulation include relieving the problem of asymmetric information, protecting moderate competition, ensuring the effective supply of public goods and increasing the effective supply of non-market value goods. Chapter two: Historical vicissitude and current status of drug government regulation. From the American history of drug regulation, we can see that the scope of government regulation of drug is becoming larger and larger while the intensity is getting higher and higher. With the development of science and society, the concepts of public health and drug safety and effect all change. The new thought of the role which FDA plays in protecting public health is put forward. China is still in transition to market economy and drug market needs further development. The Chinese drug government regulation is faced with both universal and special problems, i.e. market failure, backward industry and system barrier. Thus the drug regulation agency has to play double roles.Chapter three: the re-creation of the fundamental principle of drug government regulation. According to the theory of public governance, the fundamental principle of traditional government regulation should be reshaped. In order to realize "good governance", the fundamental principle of public, cooperation, responsibility and efficiency should be involved.Chapter four: the agency of drug government regulation. This chapter firstly compares the organization modes of drug regulation agencies in America, Britain, Japan and Taiwan district. Then common experience and regularity are found which include relatively independent regulation agency, professional members and industry association. On the basis of this, it thoroughly analyzes the current status and problems of the organization of drug regulation agency in China. Then it proposes a reasonable reform plan by four aspects of organization, authorities, human resource and financial source.Chapter five: the objective, scope and method of drug government regulation drug. The objective of drug regulation is mainly social and also economical, which depends on the character of drug industry. The scope of the Chinese drug government regulation tends to enlarge accompanying relaxation during the economy transition. Except for refinement of traditional regulation method, we need to introduce new and flexible methods such as information regulation, standard regulation and credit regulation. Chapter six: the operating mechanisms of drug government regulation. The regulation is dynamic and continuous and the effect is the essence. To ensure the rationality of drug regulation, the agency is not only regulated by the substantial laws but also restrained by certain operating mechanisms. It is necessary to establish the operating mechanisms of public participation, invigorative regulation, regulation effect evaluation and government accountability.