On The Drug Regulatory System, Improve The Administrative Law Enforcement

This thesis which is about administrative law aims at providing the reference of completing China’s drug regulatory administrative enforcement. Recent years, people take drug supervision and management as a government focus and ameliorate the contents in the concrete work. While law enforcement still exits various disadvantages and problems in the real world because of the reform and development of the medical system. The purpose of this thesis is to let the readers know about the current situation and the potential problems of China’s drug regulatory administrative enforcement and offer some practical suggestions about completing drug regulatory administrative enforcement. This thesis can be divided into three parts:The first part presents the argument. Above all, generally the author introduces the process of the reform of China’s drug regulatory system and structure of the legal system which the drug regulatory administrative enforcement based on. Then, the author explains the current situation in detail from the following aspects:drug safety, drug advertising, drug commercial bribery and drug regulatory in the remote rural areas. Thirdly, the author generalizes some potential problems in law enforcement through analyzing the current situation of China’s drug regulatory administrative enforcement.From the year1949till now, China’s drug regulatory administrative enforcement system has been in the developing and transforming situation. The establishment of the State Food and Drug Administration in2003marked the completion of vertical management of drug regulatory agencies which are managed by the main central government and are the units below the provincial level. Half decade passed, at the end of2008, the State Food and Drug Administration was taken over by the Ministry of Health; and the three levels (provincial level, municipal level and county level) of drug regulatory agencies were integrated with the health sector at the same level by State Council; the mode of hierarchical management of local government takes the place of previous mode of drug regulatory. And if the local protectionism breakout under this mode, it is not conducive to clearing rights and dividing responsibilities and also the drug regulatory will be impeded and the political acts will not be implemented.Drug Administration Law of the People’s Republic which is published in1984and amended in2001is the only reference on which China’s drug regulatory administrative enforcement can base. During about the two decades, the relevant points of drug supervision and management were covered gradually and extensively. And still the Administrative regulations and normative legal documents about drug advertising, drug quality, drug market access etc. which supply and refine the short comings of the Drug Administration Law of the People’s Republic were introduced continuously. But still some matters were exposed because of the low legal level, weak coercive power and operability.In addition, these issues still exist which include that the terms are not clear, the bases are not perfect, the procedures are not standard, supervision is not reasonable and law enforcement officers are not high qualified. Even though the issues are improved actively in all aspects, it will more or less impact the legal and social effects of China’s drug regulatory administrative enforcement.The second part discusses the foreign drug regulatory systems which include Japan Pharmaceutical Affairs Bureau of the regulatory regime, Germany’s joint regulation of drug, Britain’s drug classification management and Well-known U.S. FDA management. All the drug regulatory systems share the commons and possess own features. To generalize the commons and to analyze the characteristics may give China’s drug regulatory administrative enforcement better theoretical significance and practical value.The third part is the main body of this thesis, through analyzing the current situation and the problems of China’s drug regulatory administrative enforcement and consulting and referring the commons and properties of foreign drug regulatory systems, the author conceives an effective way of completing China’s drug regulatory administrative enforcement on the basis of previous studies and China’s basic national conditions.From the perspective of developed countries’(such as United States, Britain, Japan and Germany) drug regulatory system, vertical management system is undoubtedly more good than harm. The government could clear China’s drug regulatory rights of drug regulatory agencies from all aspects so that the officers of law enforcement could perform their regulatory duties.On the scope of law enforcement of drug regulation pharmaceutical laws and regulations in developed countries which are systematic and deterrent have a higher level and stronger effect. While the government should clear up the defective laws and provide a robust legislation system. Especially the normative legal documents should be introduced by drug regulatory authorities at all levels; appropriate supporting regulations should be manifested as the supplement; the points of duplication or conflict should be abolished, and operable, comprehensive and systematic drug regulation legal system should be formed.In order to increase the transparency of drug regulatory administrative enforcement and the enforcement of internal and external oversight, the author gives some suggestions about drug regulatory procedures, drug supervision and management and the quality of personnel which include how to improve the information disclosure system and hearing procedures; how to build the fault of law enforcement accountability system and responsibility assessment system; how to enhance the regulatory standards of law enforcement officers and awareness of administration. The author insists that how importance the role of social supervision is-crack down on illegal drugs crimes and improve the personal quality and community literacy through the help of the media and the public.Furthermore, the author brings "medical representatives" and the principle of exclusivity files into the field of drug regulatory through researching and analyzing the amount of literatures and referring the management of other nation’s self-regulatory organizations and the legislation on the administrative penalties which is based on the principle of exclusivity files. For the purpose of completing the contents of the two aspects, for one thing, the government should strictly execute the access system of "medical representatives"; regulate their professional conduct; help them to be linked with the self-regulatory organizations to play a positive role, for another, the government could establish the principle of exclusivity files according to not only other nation’s legislation on the same aspect but also the China’s principle of exclusivity of administrative license files. The author takes the two points above as the innovation points of this thesis, aims at providing reference value of perfecting China’s drug regulatory administrative enforcement.Drugs are closely related to people’s life. With the development of China’s medical reform, the government should pay more attention to completing drug regulatory administrative enforcement. China is currently in the primary stage of socialism, in such a condition, the government should build a good concept of law enforcement; establish sound drug regulatory agencies; use the legal bases and procedures reasonably and legally; establish effective judicial protection mechanisms and remedies and enhance law enforcement officers’administrative concepts and personal literacy, or the transformation from legislation to law enforcement can’t be implemented and the unification of legal effects, social effects and political effects can’t be achieved.