Research On Basic Drug Supervision Under The Market Supervision System

Drug is a "special commodity" related to people's life,health and safety,and drug safety is an important livelihood issue related to the image and credibility of the party and government.Since the beginning of the 21st century,despite the continuous reform of China's drug regulators,a number of drug safety incidents have occurred,such as "illegal vaccine case in Shandong province","fake drug case in Heilongjiang province","Hongmao liquor case",and "Changsheng vaccine case".It not only endangers the lives of the people,but also brings a heavy blow to the drug regulatory system and drug manufacturing industryThe drug regulators at the district and county level in China are the most grassroots drug regulatory departments,which are the first position of supervision.Their executive power is directly related to the smooth implementation of relevant policies formulated by the state,the quality of drug market order,as well as the image of the drug regulatory system and the authority of laws.As the last line of drug safety supervision,district and county bureaus are responsible for the safety of drug use.At the grassroots level,there are many problems,such as fewer supervisors,fewer professional and technical personnel,more regulatory units and weak technical support.Therefore,it is urgent to strengthen grassroots drug safety supervision.Since 2013,China's district and county-level drug regulators have undergone the"three-in-one" system reform,namely integrating the functions of the former industrial and commercial bureau,quality supervision bureau and food and drug administration,and establishing the market supervision and administration bureau.The purpose of the "three-in-one" market regulation mode undoubtedly reflects the party and national attention to the food and drug supervision,but the market regulatory model for specialized drug regulatory or produced a certain impact,reform of the turmoil,department integration difficulties,the differences between the regulatory model instead weakened the drug regulatory effect,many problems still exist in grassroots drug safety.Taking Qixia district of Nanjing city as the sample,this paper analyzes the problems and causes of grassroots drug supervision under the "three-in-one" system,and puts forward some countermeasures and Suggestions.This paper takes Qixia District of Nanjing as a sample to analyze the basic drug regulatory issues under the current "three-in-one" supervision system,and proposes targeted solutions.Firstly,through the development process of China's drug regulatory system and the reform of pharmaceutical institutions in Qixia District of Nanjing,the research background of this paper is introduced.By summarizing the research literatures related to the supervision of grassroots drugs at home and abroad,the basic drug supervision system is analyzed.The problems existed in the design of the research framework system based on these problems.Secondly,it expounds the related concepts of drug safety supervision involved in this article,and explains some proper terms such as drugs,basic drug supervision,and"three-in-one" system,and analyzes its characteristics.This paper introduces the theory of holistic governance,the theory of information asymmetry and the theory of risk management,and constructs the theoretical system of this paper based on these theories.Then,through a brief introduction to the development process of the drug supervision system in Qixia District of Nanjing,the case of drug supervision in Qixia District was introduced,and the current drug regulatory agencies,functions,personnel and regulatory targets were introduced,and the supervision before and after the "three in one" reform was analyzed.The situation has changed,summarizing the positive effects of the "three-in-one"system reform on drug regulation in Qixia District.And deeply analyze the problems and causes of drug safety supervision in Qixia District.Excavating the difficulties of departmental integration and supervision mode existing in grassroots supervision,the professionalism of supervision power,the lack of supervision means,the poor linkage between departments and the decline of investigation and punishment of cases,based on grassroots,analyzing the current development problems in the overall drug regulatory system in China.Finally,through the comparative study of the three market supervision modes of Shenzhen,Zhejiang and Tianjin,and drawing on the advanced experience of some regions in China,the countermeasures and suggestions for improving the safety supervision of grassroots drugs are further proposed.Based on strengthening departmental integration,innovative supervision methods,enhancing supervision power,and improving the effectiveness of supervision and enforcement,we propose specific improvements and development opinions for improving China's drug supervision system,so as to better promote China's grassroots drug supervision system to play in market supervision.