On The Administrative Regulation On Drugs In China

As a particular kind of commodity, the safety of drug's quality is of great importance to people's health and lives. Therefore, in order to guarantee people's security of having drugs and reduce the risk of it, the government must guarantee the drug's quality and meet people's need for drugs by formulating related regulations and making certain interference. From the perspective of administrative law, and on the basis of study on the existing administrative regulation on drugs, the author puts forward suggestion about how to improve the system of administrative regulation on drugs after analyzing the particularity of the issue of drugs, making introduction to the usage of administrative regulations to regulate drugs and drawing lessons from American and British administrative laws on drugs.The thesis falls into four chapters:Chapter one is the analysis of the issue of drugs. Firstly, it comes to the definition and characteristics of drugs. The characteristic of drugs is mainly reflected in the four aspects of duality, special-purpose, importance of quality and economic benefit. The following part of this thesis is the analysis of the particularity of issue of drugs, which is mainly reflected in the three aspects of quality of drugs causing the health risk, insufficiency of drugs supply violating the human rights and dissymmetrical information harming the consumer's benefits. Because of the characteristics of drugs and the particularity of issue of drugs, we must guarantee consumers'security of having drugs and reduce the risk of it by implementing strict and suitable administrative regulation on drugs, guaranteeing drugs'quality, the supply of drugs and consumers'obtaining general and detailed information of drugs.Chapter two is the summary of administrative regulation on drugs. Firstly, it comes to the definition of these regulations, namely the control by the main bodies with authority who adopt special means of administration or legislation and judicature on the admission into market and the producing and circulation of drugs according to certain regulations. Secondly, it introduces the main body to regulate drugs by means of administrative regulation. Thirdly, it analyzes the object regulated by related administrative regulation, which mainly includes the drug, drug dealers and their behavior and consumption of drugs. The drug is the most important content of administrative regulation on drugs. The drug dealers and their behavior are also the momentous contents. To regulate drug dealers is mainly to confirm and supervise their qualification. The drug market behavior mainly includes the research and exploration of drugs, the production of drugs, the dealing of drugs, and advertising for drugs. There's need to use legal measures to regulate the prescription of drugs, fake drugs and low-quality drugs. Then it analyzes the measure of administrative regulation on drugs. Apart from the traditional measures, such as administrative permission, administrative punishment (administrative sanction), administrative compulsion and so on, it also includes the regulation on information, standards, recall of the drugs, management on classification of drugs, and regulation on price of drugs and advertising. Lastly, it points out the important significance of administrative regulation on drugs, namely guaranteeing the drug's quality, safeguarding the consumer's basic medication, and eliminating the risk resulting from the dissymmetrical information.Chapter three is the introduction to American and British main system of administrative regulations on drugs. In the aspect of main body to regulate drugs by means of administrative regulations, America and Britain both set up quite independent, authoritative authorities to implement the centralized and unified regulation to the drugs, and they are apt to set up independent authorities, such as Food and Drug Administration with more emphasis on specialities of its members. In addition, the Intermediary organizations play an important role in administrative regulation on drugs. In the aspect of system and means of administrative regulation on drugs, system of publicity of information and recall of drugs in USA, price system in Britain are of great significance to our country.Chapter four is the elaboration of improvement on the system of administrative regulation on drugs in China. Firstly, it points out the present situation and existing problem of our country's administrative regulation on drugs. Presently, our country's main bodies of administrative regulation on drugs are the administrative authorities which mainly include State Food and Drug Administration and those at provincial level. The problems in our country regarding main body to regulate drugs by means of administrative regulation are mostly reflected in the following several aspects: First, at present, the vertical system consisting of State Food and Drug Administration and those authorities at provincial level is not vertical supervision. In the practical process of organization and operation, this system has some problems which can't be to overcome in a short period of time. Second, the administrative authorities on drugs lack the supervision authority. Third, the members administrative authorities on drugs in China are not professional and neutral as required. Fourth, administrative supervision on drugs is in vacancy. Till now, systematic legal system of administrative regulation on drugs in China has been formed. Related system and means of administrative regulation on drugs mainly include the system of administrative permission, the system of approval, the system of drug standard regulation, the system of management on classification of drugs, the system of drug price and advertisement regulation, the system of drug recall, the system of control and the system of reporting bad reaction caused by drugs, the system of label and instruction and so on. But there still exists some problems, for example, the application of related laws and regulations is inferior and amendment to them is not prompt, systems and means of administrative regulation on drugs also needs further improvement. Secondly, it put forwards suggestion about how make the main bodies to regulate drugs by means of administrative regulations in China more eligible. For instance, the administrative authorities with power of supervision must be independent, legal and specialized. The authorities should have the accurate legislative power, the executive power, and the accurate jurisdiction. They should enhance the transparency of administrative activities to realize the publicity of regulations and rules, process and result, and also the authorities'internal restriction, as well as their outside supervision should be strengthened. Lastly, it puts forward the suggestions regarding the improvement on the system and means of administrative regulation on drugs in China. As far as the author is concerned, in the system of drug appraisal, we should fully exert the experts'action, confirm the experts'authority and establish the corresponding relief mechanism; In the system of price regulation, we should make it available the system of hearing on drugs; In the system of drug standard regulation, we should require the main body formulating standards on drugs to make certain standards according to legal procedures by taking the legality as the starting point in consideration; In the system of reporting bad reaction caused by drugs, we should improve the mechanism of publicizing the bad reaction caused by drugs, confirm the various departments'responsibility in mechanism and establish the mechanism of compensating suffers; In permission and authentication process, we need strengthen the verification to the drug instruction and the content of bad reaction caused by drugs on the label; In the system of publicizing information, we must guarantee that the content is comprehensive, the action of publicity is voluntary, timely and accurate and the diversification of ways of publicity; Adopting the system of hearing procedure and the negotiation in the implementation process of administrative regulation drugs, will make the regulation more democratic, scientific and transparent, and will be ensure and realize the benefit of all related parties.