Study Of The Legal System Of China's Pharmaceutical Market Access

Drugs is a special commodity closely related to the health and life security of social public. Once lacking of governmental supervision and restriction, several problems will be caused. Therefore, countries of the world manage the research, production, circulation, and usage of the drugs strictly. A series of legal institutions issued to regulate the steps mentioned above. The primary institution is the legal institutions of drugs market access. It is of great significance that, as the first step of accessing drugs market, the legal institutions of drugs market access directly relates to the difficulty and level of further supervision.In recent years, safety accident of drugs happens frequently in our country, which has exposed the defects of the legal institutions of drugs market access. Therefore, it is necessary to study the legal institutions of drugs market access deeply to analyze its problem and causes and set forth the improving suggestions. Thus this article will explore the general theories of the legal institutions of drugs market access first. Then introduce the legal institutions of drugs market access of our country. And finally, suggestions for the perfection of the legal institution will be proposed. Besides the preface and concluding remarks, this article will include three parts and it will have about 300, 00 words.The first part is the discussion of general theories of the legal institutions of drugs market access. Firstly, after reviewing the connotation and extension of market access, the author holds that the legal institution of drugs market access means the general term of a series of laws and regulations which, for the safety, stability, order and the safe use of drugs, are made by the government or country in light of lawful authority to regulate drugs producers, operators at home and abroad and the conditions and processes of drugs market access. The institution has the characters of diversified regulating object, multi-levels and comprehensive regulation system, universal technical regulations, comprehensive regulating means and strict legislation model and so on. Secondly, the author will draw an analogy between the legal institution of drugs market access and economic law from the angles of value orientation and regulation nature by the means of comparative analysis. Then the author will examine the specialty, information asymmetry and monopoly of drugs market. Finally, the author will discuss the economics basis and law basis for the origination of the legal institution of drugs market access.The second part is the concluding of our country's drugs market access legislation. First of all, the authors will exam legislation history of our country's drugs market access and conclude that our country's drugs market access have experienced three periods after the establishment of China PR. The first period was from 1949 to 1970s. The second period was from 1970s to 1990s. The last period has been lasting from 1990s till now. As the following, the authors will exam the organization establishment of our country's drugs market access to conclude that, after two rounds of reforms in 1998 and 2003, for the establishment of supervision organization of drugs market access, our country has formed normative and perfect administrative organization system. Finally, examination and approval system, GMP certification system, GSP certification system and drugs registration system will be introduced by the means of systematic analysis.The third part is the suggestion for the perfection of our country's institution of drugs market access. First, the author will conclude the problems existing in our country's legal institution of drugs market access and then analyze the cause. The author holds that there still are some problems in our country's legal institution of drugs market access, such as confused regulation systems, difficult law application, extremely strict access condition, and so on. The main causes are that the history of our country's legal institution of drugs market access is short, the institution has not mature enough, placing more emphasize on the safety and the influence by long term plan economy. As the following, the author will analyze the causes based on the problems above. And then the cope strategies will be set forth.