Study On The Administrative Acceptance Of Drug Registration In China

With the deepening of the administrative system reform by government streamlining,power delegation and tightened oversight,since 2015,the reforms of drug registration evaluation and approval system has entered a white-hot stage.Drug registration supporting acts were frequently issued,application procedures,registration classification,data requirements,and guidelines have been adjusted accordingly.As the starting link of the drug registration administrative permission,administrative acceptance is the first link to be impacted by reforms.In order to better comply with the reform requirements of administrative system,further integrate with the subsequent evaluation and approval links,administrative acceptance function has adjusted from provincial drug regulatory departments centralized to national drug regulatory department.Facing the new departments,new items,new classifications and new requirements,the impact of the drug registration acceptance management is huge,in the process of constantly improving and summarizing experience,some problems in management appeared inevitably.Although the work of administrative acceptance in China has been carried out for many years,it still lacking the guidance of relevant legal theories.The administrative acceptance of drug registration involves the whole pharmaceutical industry,which involves a wide range and influences a large area,it needs effective institutional support in practice.First,this study traces the source of legal theory,and starts from the concept of administrative act,to define the connotation,legal boundary and compliance requirements of administrative permission acceptance,to clear the boundary and direction for subsequent research.Secondly,this study reviewed the initial,formation,development and improvement stages of drug registration administrative acceptance of in China,and conducted an empirical questionnaire survey on the status quo of administrative acceptance service quality,which reference to SERVQUAL evaluation table.It was found that improving the responsiveness of the service was an urgent problem to be solved at present,the problem can be fundamentally solved from three aspects:clarifying the management goal,simplifying the acceptance process and constructing the security system.Finally,based on the excellent experience of drug registration acceptance related systems in Europe and the United States,as well as the development model of domestic government services,this study clarified the acceptance review scope and content,and constructed four supporting systems——the administrative information openness,tolerance defects acceptance,notification and explanation,supervision and assessment.Guided by the theory of "seamless government",carded existing acceptance review process,targeting customer demands,using the means of the prior policy guiding,versatile communication,serial to parallel,one-time get information source place,"starting from a clean SLATE" to describe the process of drug registration administrative acceptance review.This study is the first systematical study on the drug registration administrative acceptance.From jurisprudence and practice,this paper tries to clarify the legal position and system requirements,and provides improvement suggestions for the current administrative acceptance management.