Research on Drug Regulatory System
|School||Changchun University of Science and Technology|
|Course||Constitutional and Administrative Law|
|Keywords||Drug regulatory system Drug approval Drug Recall|
In2012"poison capsule" event raised again to the attention of drug supervision system, after the drug safety accident we recognize our drug safety supervision department according to the raw material drug regulatory existence of loopholes, at the same time in drug production links are regulatory loopholes. These regulatory loopholes brought harm is immeasurable, so in order to avoid drug safety accident to the public, the dangers of drug supervision departments should strengthen the drug from the production, research and development, sales, use and other links to strict and effective supervision, so as to safeguard the lawful rights and interests of the public. Drugs for human beings is a special kind of commodity, because of this country should be based on the particularity of drugs and drug supervision mechanism, improve drug regulatory laws and regulations.This paper is divided into four parts.The first part, drug supervision system overview. In China, through the introduction of the relevant laws and regulations on drug concept definition, not only fully understand the concept of medicines in China, and fully mastered the types of medicines in China. Then the characteristics of drug supervision of detail, first, the drug regulatory body has specificity, drug regulatory authority is the specific drug regulators to exercise, the state food and drug administration is China’s drug regulators. Second, the statutory sexual of drug supervision object, this is mainly because drug regulatory objects are made by specific laws and regulations to determine the down. Third, drug supervision mode of professional and technical, it is to point to drug is a special commodity, to realize the effective supervision on drug drug regulators should use professional testing technology and professional pharmaceutical knowledge to drug market supervision. Fourth, drug supervision content multifarious sex, is mainly due to the function of the drug is not just limited to cure the disease as well as part of the drug has the function of health care, according to the diversity of the pharmaceutical function, so the drug supervision staff the supervision standard and inspection way is different. Fifth, drug supervision task, is due to the long-term nature of the drug will be long term with the survival of mankind, so to the supervision of the pharmaceutical market is of long standing. In this part of the theory basis of drug supervision are introduced, drug supervision system are mainly is by the information asymmetry theory, market failure and government intervention theory to support, based on the introduction of the two theories of Chinese government to fully reveal the drug market strict supervision to achieve the purpose of supervision.The second part, mainly developed drug supervision system and their inspiration to China. This part is mainly through the comparison of foreign developed countries advanced drug supervision system, mainly to the United States, France, Britain, Germany, Japan and other countries of advanced drug supervision system is introduced. American drug supervision level in the world leading level, so the drug supervision system in regulatory measures is worth reference for other countries. In Europe, although there are the European Union and drug administration to the European region drug market supervision, but there is also a member of the European Union and the relative independence, and the situation of the various countries also have different places, so there are many members in their range set up corresponding drug regulators, and according to its national conditions to the implementation of the drug regulatory behavior, Britain, France and Germany are in drug supervision has made the good progress. Japan’s pharmaceutical industry is developing rapidly a country, this is mainly due to Japan in recent years to fully understand their own drug supervision system deficiency, and take the appropriate way to make their own drug supervision system gradually mature, so as to guarantee its healthy and orderly development of the pharmaceutical market. From the country’s drug regulatory development situation, we must face up to the domestic drug supervision, learning problems in the United States to set up a high level of drug supervision team, so as to ensure the authority of the drug supervision effectively exercise, need according to their own situation to other developed nations to study advanced drug supervision system.The third part, China’s drug regulatory system problems. Our drug supervision system problems mainly from the five aspects to carry on the analysis. First, the relevant drug laws and regulations is not perfect, although in recent years the government issued a lot and drug regulatory relevant laws and regulations, but the drug safety incidents state to see our drug regulatory laws and regulations there are legislation gap. Second, drug regulatory body relatively narrow, drug supervision main stenosis is easy to cause the drug regulation is not in place, therefore in the process of drug supervision shall be made part of the non-governmental regulatory agencies involved in the drug supervision of. Third, the drug approval system existence of loopholes, drug approval, the examination and approval work standard is not consistent cause, it is virtually increased the difficulty of the examination and approval and reduce the drug supervision efficiency. Fourth, the false illegal advertisement flood, because the false drug ads to potential illegal drug producers bring huge economic benefits, this makes drug false advertising repeated the more than. Fifth, drug recall system defects, because of the pharmaceutical market main body can’t face drug recall system, which affect the drug recall system to realize its value.The fourth part, perfect our country’s drug supervision system of the main countermeasures. In order to perfect our country’s drug supervision system, should from the following five aspects:first, to improve the legal system, perfect the drug supervision by are suitable for the situation of China’s current drug laws and regulations, and pays great attention to the violation of drug supervision and cause serious damage to the conduct of the strict punishment, at the same time also need to improve the maneuverability of the law. Second, realize the diversification of the main drug supervision, nongovernmental drug supervision organization can effectively cooperate with the national drug supervision and administration work, make the healthy development of the pharmaceutical market. Third, improve the drug approval system, and adopt more reasonable and effective way to improve the examination and approval of the drug supervision department approval efficiency. Fourth, to strengthen the supervision of the false illegal drug advertisements, advocate public participation of false drug advertising to the supervision of the behavior, the government departments to crack down on fake drug advertisement publicity of behavior. Fifth, improve the drug recall system in the developed countries for reference, through the drug recall system in legislation and drug recall system related system construction constantly improve the drug recall system in our country, so it can realize the drugs have already been put into use for effective supervision.