A Research On Administrative License Of Drug Manufacturing Market Access System In China

Drugs and pharmaceutical market is unique, so safe and effective drugs and medicines orderly market is an important issue related to people’s livelihood. Therefore, governments around the world have taken measures to establish a legal system on the regulation of medicines and pharmaceutical markets. Among them, government regulation of the pharmaceutical manufacturing market access as the first part of both government regulation of medicines and pharmaceutical markets starting point is the basis for the subsequent series of regulatory measures, which is of great practical significance. According to the<Administrative Licensing Law>,<Drug Administration Law>,<Drug Administration Law Implementing Regulations> in China, and other laws and regulations, China has established a very typical pattern of drug production license system for market access, on the part of pharmaceutical production and market access regulation to ensure drug quality and the public safe and effective medication.From the perspective of administrative licensing, production and market access of drugs to explore, to market access for pharmaceutical production and regulatory practices help. The first part focuses on the supervision of pharmaceutical production and market access of the general theory of administrative licensing, through drugs, drug production market, the analysis of the characteristics of the administrative license, described the production of market access regulation and the concept of administrative licensing, market access for pharmaceutical production Supervision into the connotation of an administrative license defined. The second part does the sort legislative history of pharmaceutical production and market access to China’s legal system, discussed China’s current administrative license pharmaceutical manufacturing market access and the main content of the main set, based on analysis of existing problems and reasons, including: the main administrative licensing confusion, resulting in difficulty in application of law; As a result of the coexistence of license and GMP certification system, resulting in substantial secondary access for pharmaceutical production; the permit system to coexist with the approval of the text system, resulting in the effect of "drug production licenses " reduced and the excessive concentration of power. The third part introduces the pharmaceutical production in other countries market access provisions of the administrative license, such as the U.S. FDA, the EU’s drugs, "marketing authorization" and "the production of Licensee" phase separation system, Japan’s Pharmaceutical Affairs bureau that the countries of the pharmaceutical manufacturers and drug itself provides for strict access conditions, access to domestic and international system of drug production is mainly reflected in differences in the implementation of administrative licensing medicines and the sequence of GMP inspection time. The last part of the theory and practice in the previous analysis, based on the subject from the administrative licensing regulation, pharmaceutical manufacturers licensing and product licensing and other aspects of a sound monitoring of pharmaceutical production and market access proposals in the administrative licensing system.