Study On The Problems And Countermeasures Of HZ Drug Supervision And Management

Medicine is a special commodity,the safety of its production and processing is directly related to human life and health.As an important guarantee for the safety of people's lives,it plays an important role in safeguarding the health and safety of human life.However,in recent years,major drug incidents also occur frequently with the continuous development of the market economy.In particular,the illegal vaccine case of Mr.Pang,worth ? 570 million,was cracked in Shandong Province in March 2016,which pushed the drug regulatory department to the forefront of the storm once again and exposed the problems in China's drug regulatory system profoundly.It has caused the huge negative impact to the society.Since 18th national congress of the CPC,the State Council has attached great importance to the work of food and medicine.Mr.Xi made important instructions on many occasions,and put forward the "four strictest" requirements for food and drug safety,that is the strictest standards,the strictest supervision,the strictest punishment,the strictest accountability.Besides,he has regarded this as the basic standard and fundamental requirement for the work of food and drug safety during the "13th Five-Year".Premier Li Keqiang also stressed that food and drug safety concerns the health of people and it must be strictly regulated in?the Government's work report?at March this year.Thus it can be seen,the CPC's understanding of food and drug safety work has reached a new height.Shandong is a major province in the pharmaceutical industry.In 2017,The total output value of the pharmaceutical industry in the province reaches ?526.2 billion,accounting for 16.2 percent of the total output value of the national pharmaceutical industry,Which The scale of medicine ranks first in our country and it is an important production and supply base in the country.Therefore do a good job of the province's drugs,not only related to Shandong itself,but also affected the country.At present,drug safety is still in the special period of "frequent problem" and "weak supervision".From the point of drug regulatory system,Shandong drug safety work started late,foundation is weak,inadequate regulatory resources and less supervision staff,professional level is not high,imperfect laws and regulations bring some difficulties in drug effective regulation.Therefore,we must resolutely implement the "four strictest"requirements put forward by general secretary Xi Jinping,take "food an Shandong" as the leader,establish and perfect the drug safety supervision system,innovate the mode and means of supervision,further "improve the quality of drugs,ensure the safety of drugs",and improve the level of drug safety and supervision and guarantee in an all-round way.Power.This study is divided into seven parts to discuss.In the first and the secondpart,the author summarizes the research background,the research significance,the research status,the research method and the research innovation point both at home and abroad;And the related definitions of drug regulation and administrative reform are defined as well.These theories and definitions are helpful to the reform of HZ city.At the same time,since the China's reform and opening up for 40 years,the reform process of China's drug regulatory agency were introduced detailedly.The third and the fourth part focuses on taking HZ city,so as to review and analyze the present situation of the drug and the drug safety events of city in recent years.On this basis,it points out the main problems existing in the supervision and management system of drugs in HZ city.The fifth part,through the introduction of the FDA drug regulatory system in the United States,new drug approval system and the advertising management system of the three major drug supervision and management system to introduce,to provides some reference suggestions for HZ drug supervision and administration system,such as speeding up the construction of professional team,establishingand perfecting training system and strengthening international cooperation.In the sixth part,On the basis of summing up the present situation of domestic practice and drawing lessons from the development of foreign countries,this paper puts forward some reasonable suggestions to optimize the reform of drug supervision and management in HZ city,to innovate the way of supervision,to perfect the supervision rules,to manage plural,and to supervise intelligently.Finally,the conclusions and shortcomings of this study are summarized and prospected.