The Plight Of Grass-roots Drug Regulatory And Solution

Drug safety is in relation to life and heathy of the broad masses, therefore, drug supervision is an important work that we must firmly grasp. Since 1998, our drug regulatory system is further deepening reform, medicine industry have been developing rapidly, drug regulatory made remarkable progress, howerer, the fake hydrophobic vaccine case, counterfeit drug case of Shaoyang and Loudi of Hunan province in 2003, Qier, Xinfu counterfeit case in 2006, issue eye event of Shanghai people's hospital in 2010, we illustrate a fact - our drug regulatory exist loophole.In this context, this article begin with the theory of government regulation, on the basis of theoretical research on difficulties of China's grassroots drugs supervision and analysis to find reasons, at last attempt to make a realistic solution.The article is divided into four parts altogether. The first part from regulatory theory expounded from government regulation and drug regulatory meaning, and briefly introduces the history of drug administration in China.In this part, starting from government regulation theory is introduced from etymology, starting with what is supervision, and through a comparison of the various definitions of regulatory legal meaning is obtained, and then, by comparison, analyzes the meaning and the government supervision from the four aspects of the main characteristics of government regulation is the specific institutions should be the government, supervision object is microeconomic fields, use means is laws, regulations, etc, the purpose is to correct market failures, and to safeguard the public interests, and classified, and points out that the government regulators have mature the three conditions: institutions professional, independence and quasi legislative and administrative power and quasi jurisdiction at a suit. Below, this paper expounds the definition of drug supervision, and explains its nature and causes, and general supervision of international practices introduced. After this, the article introduces the establishment of drug supervision system in China, and achievements process, and remind us that in recent years, JiaLie drug events happen repeatedly, show the drug regulatory especially grassroots drug regulatory exist problems.The second part, based on the actual situation of grass-roots drug regulatory analysis, it is concluded that the drug supervision at the grassroots level, the existing problems of the subject from drug supervision, and analyzes the reasons of the problem. The article points out that our drug regulatory analysis of main himwith functions and loss, external disturbance serious, and drug regulators and lack of regulatory facilities; From the analysis on regulatory means, and points out that the grassroots drug regulatory legal existence legislation, and other legal conflict blank and can be operational difference weaknesses; Pointed out on the object from a regulatory oversight of the object is basic drugs drug operators and users, both to the pursuit of profit, relaxed to own request, reduced access to medicines market standard, to a certain extent, reduced the drug quality, the counterfeit drugs and the inferiordrugs caused the spread. Secondly, for drug supervision and management in China at present in the grass-roots, analyzes the reason why predicament, and points out that only exist such problems, because our drug regulatory system is imperfect. Although our country has preliminarily established drug supervision system, but the regulatory system is not mature, from regulatory body said lack of professional and independence, from supporting law said, no perfect legal system for its support.The third part,through foreign and some parts of the country experience, the article points out that our country should draw comparison of experience. The article to the FDA's regulatory model, the eu, including Germany and France regulatory model, Japan's drug regulatory system are introduced, and learn from their regulatory system: see, these countries are set up for themselves the oversight system, national characteristics with independent regulators; These countries can form relatively perfect drug regulatory legal system, whether from the quantity or quality, can achieve a higher standard; These national regulatory responsibilities, regulatory scope and fine; These national regulators have strong professional; These countries are clear and punishment legal liability severity. Meanwhile, China's Shanghai compared the vertical supervision mode and Beijing is paid upon mode, points out of Shanghai should learn from the vertical administration, and in the work ahead to paid to snap.The last part, this article put forward in reference to the basis of domestic and foreign advanced experience, combined with actual situation in China, forming a complete subject, supporting the laws and regulations, and the way of supervision with a modern drug monitoring system.In this part, complete the main need regulatory functions in clear, regulators supplements, introduction of professional talent training, regulatory independence protection and supervision level reset; Supporting the laws and regulations of the complete including the legislative blank legal conflict make up and avert and lack of feasibility legal adjustment. Based on the proposed law enforcement means modernization, mainly introduced the Internet supervision construction and the establishment of credit files in two ways. To build a network platform, for information disclosure and real-time on drug operators and users regulation. The supervision in fact become the static dynamic supervision and regulation of the union. The establishment of credit files to be regulators are regulators from the evaluation, credit to a certain extent, guide people better consumption. At the same time, establish the ngo is the beneficial supplement of the government supervision.This article lies in the novel by way of combining theory with practice, through investigation, obtains the firsthand material, make as far as possible, to combine the actual data objectively, and puts forward some practical and effective drug regulatory reform effort.