The Legal Regulation Of The Drug Industry On The Market Background

This thesis which is about administrative law aims at providing the reference ofcompleting China’S drug regulatory administrative enforcement．Recent years，peopletake drug supervision and management as a government focus and ameliorate thecontents in the concrete work．While law enforcement still exits various disadvantagesand problems in the real world because of the reform and development of the medicalsystem．The purpose of this thesis is to let the readers know about the current situationand the potential problems of China’S drug regulatory administrative enforcement andoffer some practical suggestions about completing drug regulatory administrativeenforcement．This thesis Can be divided into three parts：The first part presents the argument．Above all，generally the author introducesthe process of the reform of China’S drug regulatory system and structure of the legalsystem which the drug regulatory administrative enforcement based on．Then，the author explains the current situation in detail from the followingaspects：drug safety, drug advertisin9，drug commercial bribery and drug regulatory inthe remote rural areas．Thirdly, the author generalizes some potential problems in law enforcementthrough analyzing the current situation of China’S drug regulatory administrativeenforcement．From the year l949till now, China’S drug regulatory administrative enforcementsystem has been in the developing and transforming situation．The establishment ofthe State Food and Drug Administration in2003marked the completion of verticalmanagement of drug regulatory agencies which are managed by the main centralgovemment and are the units below the provincial level．Half decade passed，at theend of2008，the State Food and Drug Administration was taken over by the Ministryof 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 StateCouncil the mode of hierarchical management of local government takes the place ofprevious mode of drug regulatory．And if the local protectionism breakout under thismode，it is not conducive to clearing rights and dividing responsibilities and also thedrug regulatory will be impeded and the political acts will not be implemented．Drug Administration Law of the People’S Republic which is published in l984and amended in2001is the only reference on which China’S drug regulatoryadministrative enforcement Can base．During about the two decades，the relevantpoints of drug supervision and management were covered gradually andextensively．And still the Administrative regulations and normative legal documentsabout drug advertisin9，drug quality, drug market access etc．which supply and refinethe short comings of the Drug Administration Law of the People’S Republic wereintroduced continuously．But still some matters were exposed because of the low legal level，weakcoercive power and operability．In addition，these issues still exist which include that the terms are not clear, thebases are not perfect，the．procedures are not standard，supervision is not reasonableand law enforcement officers are not high qualified．Even though the issues areimproved actively in all aspects．it will more or less impact the legal and social effectsof China’S drug regulatory administrative enforcement．The second part discusses the foreign drug regulatory systems which includeJapan Pharmaceutical Affairs Bureau of the regulatory regime，Germany’S jointregulation of dru9， Britain’S drug classification management and Well-knownU．S．FDA management．All the drug regulatory systems share the commons and possess own features．Togeneralize the commons and to analyze the characteristics may give China’S drugregulatory administrative enforcement better theoretical significance and practicalvalue．The third part is the main body of this thesis，through analyzing the currentsituation and the problems of China’S drug regulatory administrative enforcement and consulting and referring the commons and properties of foreign drug regulatorysystems，the author conceives an effective way of completing China’S drug regulatoryadministrative enforcement on the basis of previous studies and China’S basicnational conditions．From the perspective of developed countries’(such as United States，Britain，Japan and Germany)drug regulatory system， vertical management system isundoubtedly more good than harm．The government could clear China’S drugregulatory rights of drug regulatory agencies from all aspects SO that the officers oflaw enforcement could perform their regulatory duties．On the scope of law enforcement of drug regulation pharmaceutical laws andregulations in developed countries which are systematic and deterrent have a higherlevel and stronger effect．While the government should clear up the defective lawsand provide a robust legislation system．Especially the normative legal documentsshould be introduced by drug regulatory authorities at all levels； appropriatesupporting regulations should be manifested as the supplement； the points ofduplication or conflict should be abolished，and operable，comprehensive andsystematic drug regulation legal system should be formed．In order to increase the transparency of drug regulatory administrativeenforcement and the enforcement of internal and external oversight，the author givessome suggestions about drug regulatory procedures， drug supervision andmanagement and the quality of personnel which include how to improve theinformation disclosure system and hearing procedures；how to build the fault of lawenforcement accountability system and responsibility assessment system；how toenhance the regulatory standards of law enforcement officers and awareness ofadministration．The author insists that how importance the role of social supervisionis--crack down on illegal drugs crimes and improve the personal quality andcommunity literacy through the help of the media and the public．Furthermore，the author brings“medical representatives’’and the principle ofexclusivity files into the field of drug regulatory through researching and analyzingthe amount of literatures and referring the management of other nation’S self-regulatory organizations and the legislation on the administrative penalties whichis based on the principle of exclusivity files．For the purpose of completing thecontents of the two aspects，for one thin9，the government should strictly execute theaccess system of“medical representatives”；regulate their professional conduct；helpthem to be linked with the self-regulatory organizations to play a positive role，foranother，the government could establish the principle of exclusivity files according tonot only other nation’S legislation on the same aspect but also the China’S principleof exclusivity of administrative license files．The author takes the two points above asthe innovation points of this thesis．aims at providing reference value of perfectingChina’S drug regulatory administrative enforcement．Drugs are closely related to people’S life．With the development of China’Smedical reform，the government should pay more attention to completing drugregulatory administrative enforcement．China is currently in the primary stage ofsocialism，in such a condition，the government should build a good concept of lawenforcement；establish sound drug regulatory agencies；use the legal bases andprocedures reasonably and legally；establish effective judicial protection mechanismsand remedies and enhance law enforcement officers’administrative concepts andpersonal literacy，or the transformation from legislation to law enforcement can’t beimplemented and the unification of legal effects，social effects and political effectscan’t be achieved．...