China's Drug Regulatory System Change Research

In recent years, China's drug regulation organization constantly change, it is one of the field that most be concerned and disputed. The first step to study is to build a target system of drug regulation, built benchmark for this study; Secondly, through the research to the status and development of American drug regulation organization, to establish a standard mode. On the basis, the change process of China's drug regulation agency and its functions are analyzed, analyzes its causes, effectiveness and the existing problems, puts forward suggestions for future reform.Public regulation built up for the defect of market, the supply of regulation subject to social and economic conditions and the policy of the government targets. Drug regulation is the use of government regulation in pharmaceutical field, the core is to ensure the safety of drugs, but we should take other basic goals such as availability, quality assurance, reasonable use. The priority between multiple objectives is ever-changing, and affect the design of regulation system directly.American drug regulation agency include federal and state two parts, which are responsible for the regulation of field with different external effects. Under the pressure of a series of public crisis, the drug regulation system of American formed gradually through legal procedures, and has entered to the modern stage with the characteristics of cooperation and openness, in the background of new public management. Follows transformation of economic system and adjustment of regulation target, China's drug regulation agency establishes and provides a more effective safeguard for drug safety supervision through system design. But there are also more question affecting regulation effectiveness such as:the regulation system needs to improve legal protection, the regulation system not matching the regulation field, the regulation system need to be further perfected, the regulation mode not adapt to the needs.The next reform of China's drug regulation system should implement the concept of "top design". First, we should to coordinate the interests of all parties in decision-making level, build consensus of the whole society, formulate regulation goals that conform the level of social economic development, established guidelines for regulation system by legal. Secondly, should perfect the evaluation of public regulation system, provides the basis for design and reform of regulation system. In the system, establish the central authorities with vertical management and local authorities with Classification management, bearing different functions. in the process of transformation to service-oriented,regulatory government, should to guide,build a multiple co-government mechanism, to further explore the applying of new regulatory means,such as information supervision, general management.