A Comparative Study Of Chinese And American Drug Registration Regulation

Drug registration system as the pharmaceutical industry market permission system sub-system, is the most important aspect of drug itself into the drug market, the improvement is directly related to the follow-up supervision and the level of difficulty. The United States of America as the first drug supervision of state, registration and approval system in the drug accumulated rich experience in the theory and practice experience. As the drug control of the road has just started in China, the drug regulatory system is not mature in all aspects. Therefore, it is necessary and the United States of America in the drug registration system to do a comparison to see the differences in the two countries, supervision system, recognize the current shortage of supervision, and from the United States advanced regulation experience, improve Chinas drug supervision especially the drug registration regulation level.Series of study than the previous system in this paper, the comparison of different, it is not only to the administrative licensing theory as the main line, is a kind of administrative law interpretation from the government perspective and market unique relations between subtle. For administrative law has the nature of public law, focuses on the interpretation of the relationship between government and market is the market of the government power and behavior norms.This article begins with basic concept, step by step that excessive competition and information asymmetry is the cause of drug regulation, through the comparison of the five interventions, point out the advantage of drug supervision. A further analysis of defects in five regulation ways complement each other with each other, finally illustrates the legitimacy of existence of drug registration system. The drug registration system is mainly from the laws and regulations system, new definition, examination and approval authority, the procedures of examination and approval and follow-up supervision in five aspects:the United States of America, by comparing "perfect and operable" legislative system in the supervision of more efficient,"listed" to "innovation" as the definition of new standards more in line with review standard idea,"centralization" and "expert service" examination and approval mechanism makes the regulation more professional,"professional" and "transparent" approval process is more conducive to the prevention of corruption,"early" and "perfect" the follow-up supervision make supervision more security force. Many of the differences are not only enable us to recognize the differences, it is intuitively registration examination and approval system to improve Chinas drug offers enlightenment.