Research On The Function Integration Of Grassroots Drug Supervision After Institutional Reform

Drug quality supervision,as part of a series of measure in the new journey of"Healthy China 2030",is of far-reaching significance to protect people’s health and safety and mantain social stability.Doing drug quality safety supervision well is also an important Drug safety incidents have been happening all the time,not only damaging the vital interests of the public,but also not conducive to the shaping of the government credibility.Therefore,the country has never stopped reforming the drug regulatory system and mechanism.In order to unify the market supervision functions and establish the market supervision system,according to the requirements of the institutional reform plan in 2018,the Food and Drug Administration established by the institutional reform in 2013 was abolished,and the grass-roots drug supervision functions were assumed by the newly established Market Supervision Administration.Since then,the new drug supervision system was initially formed.But under the pattern of "big" market regulation,first-line drug regulatory in the integration of regulatory resources,enhancing regulatory power,reduce the examination and approval procedures,improve efficiency and so on,positive effects are not highlighted,but in the integration of personnel,organization,responsibilities,resources,appeared inevitable or caused by inadequate integration of all kinds of problems,such as status marginalization,different regulatory concept,professionalism,disjointed work.Based on this,this article to the new round of institutional reform as the background,select J area market regulator for the case study object,through individual interview method,case analysis and comparative analysis,to explore grassroots drug regulatory function integration problems and reasons,the purpose is to find ideas to resolve the problem of the grassroots drug regulatory function integration after a new round of institutional reform,to face problems of the drug quality supervision under the comprehensive supervision pattern,to promote grassroots drug regulatory system and mechanism of further perfecting and regulatory work better and faster development.This paper is divided into six chapters.The first chapter is the introduction,which mainly introduces the background and significance of the research,the research results on drug regulation at home and abroad,as well as the overall thinking and research methods used in this paper.The second chapter mainly introduces the definition of related concepts and theoretical tools involved in this study.The third chapter introduces the development process of drug regulation in District J,the case study of this paper,as well as the status quo of functional integration of regulatory personnel,institutions,responsibilities and resources.The fourth chapter elaborates some problems in the process of functional integration of grass-roots drug supervision,and analyzes the reasons for the problems from aspects of regulatory concept,organizational structure and resource allocation.Chapter five analyzes the practical and problem solving experience of functional integration of drug supervision in Shenzhen,Tianjin,Zhejiang and other parts of China.The sixth chapter,on the basis of adhering to the problem-oriented and cause-oriented,and using the relevant theoretical tools of public management,puts forward the ideas of problem solving from the four aspects of remolding the supervision concept,perfecting the supervision mechanism,strengthening the supervision power and strengthening the informationized risk classification supervision.