Study On The New Round Reform Of Drug Regulatory System In Shanxi Province(2018-2019)

Drug Safety directly affects the safety of life and health of the public.Ensuring drug safety is an important step in modernizing the country’s governance system and capacity.During twenty-three collective study sessions at the Politburo of the Communist Party of China,General Secretary Xi Jinping laid out the "four strictest" general requirements for drug safety,promoting sustained progress in the field of drug safety and making the people more satisfied,so that the public can eat safely and use it with confidence.Over the past 20 years since the establishment of the State Drug Administration,the drug regulatory system has undergone a transformation from vertical segmentation to territorial integration,and from single jurisdiction to comprehensive integration.In 2018,a new round of government institutional reform,the future of the drug regulatory system has once again become the focus of social attention.According to a new round of institutional reform plan of the State Council,drug regulation started a new model of "Whole market — Specific Drugs",and subsequently local institutional reform plans were launched.According to the institutional reform plan of Shanxi Province,in October 2018,the Drug Administration of Shanxi Province was established to take charge of the supervision and administration of drugs,medical devices and cosmetics in the province.This paper studies the goal of the reform of the drug regulatory system in Shanxi Province,seeks its reform logic,analyzes the current reform results and existing problems,and probes into the resistance faced by the reform of the drug regulatory system in Shanxi Province,it will help deepen the understanding of the drug system reform in Shanxi Province,scientifically grasp the Development Direction of the drug system reform in our province and even in the whole country,so that it can effectively adapt to the new normal of the development of the market economy,push forward the reform of drug regulatory system in our province,so as to promote the sustained and healthy development of drug regulatory cause.The research content of this paper mainly includes four parts.The first part is to discuss the target,logic and content of the new round of drug regulatory system reform in Shanxi Province.Based on the document contents of Shanxi Province’s organization reform program and other related documents,this paper expounds the overall objectives of the new round of drug regulatory system reform,and summarizes the Functional Division,organization setup and subordinate relationship of the drug regulatory departments,we also compare the drug regulatory system before and after the reform,and analyze the "Whole market — Specific Drug" regulatory model to find out the logic behind the reform.The second part is the achievements and problems of the new round of drug regulatory system reform in Shanxi Province.The positive results of this reform are summarized and analyzed,and the existing problems are summarized.The third part is the analysis of the resistance to the reform of the provincial drug regulatory system,including the existence of institutional inertia,the interests of drug regulatory interest departments conflict,Reform Affairs of a large number of work,lack of supervision and accountability.The fourth part is the path of drug regulatory system reform in Shanxi Province.In the light of the previously analyzed resistance to reform,this paper tries to put forward specific countermeasures for advancing the reform of the drug system,including clear functions to promote internal integration,resolve the interests of the reform of contradictions,scientific reform of the affairs of the work,strengthen the supervision of Drug Regulatory Reform.