Research On The Current Status Of Registration And Approval Of New Chemical Drug Production And Marketing In My Countr

Purpose This study is made to " To analysis the current situation of registration for new pharmaceuticals and explore the hurdles of the application for marketing in China" First of all,it summarizes the basic theory related to approval system on application for new drug production,marketing and registration in our country,then gives a systematic and comprehensive analysis on the operation of the system under the background of the present approval status.On the above basis,the study summarizes the regulatory purposes,operating mechanism and operating mode of the current drug approval situation in China,and puts forward the existing problems or negative effects of the current situation of the drug approval in China,and finally,proposes a number of specific suggestions against the registration risks raised by the deficiencies of statute,in order to provide new ideas for promoting the approval rate and management system of new drug production and marketing in China and reducing the risk of research and development and advancing the reform and development of globalization.Methods Firstly.the study uses literature research method to analyze the concept connotation of "the review and approval statute of new drug production for marketing" in combination with the general foundation of regulatory theory under the background of the current policy environment,and analyzes the definition category of the review and approval system and the purpose of implementing the approval system from two perspectives:regulatory theory and industrial development.Then,it uses empirical research method to select domestic data of application for new drug production,registration and marketing in recent years as an empirical evidence to explore the actual implementation results and impact of the application and approval system of new drug production and marketing in China.The investigation dimensions include the number of applications for clinical trials,the approval rate of clinical trials,the number of applications for marketing,the approval rate for marketing,etc.,from which the major contradictions between the operational effectiveness of the current system and the objective reality of the industry can be discovered,also combination of the reasons for disapprove and the potential problems and risks in the registration process for new drug production and marketing in China will be further derived.Finally,Questionnaire survey is used to investigate the potential technical factors and policy factors that affect the quality and registration risk of new drugs in China,and used to be further supports of the accuracy for the above analysis results.Contents By referring to the historical systems and thoughts of government regulatory theory,the study analyzes and researches the review and approval system of new drug production and marketing under the general background of government supervision.Supported by the progress of the domestic and foreign research and development on the approval of new drug marketing,it analyzes theoretically the approval system of new drug marketing from a scientific perspective,and achieved the theoretical definition innovation of this system.Based on the current situation of research and development of new drugs in our country,and the demand of the public for medicines,the study analyzes the concept connotation of the new drug approval system and combines it with the implementation status of the review and approval system of new drug production and marketing in recent year,also combination of results from questionnaire survey to have a comprehensive analysis of the operation status quo and major contradictions of the system.Finally,regulatory concepts and measures conforming to the reform and development are put forward based on the existing problems to improve the innovation ability of domestic new drugs and promote the further internationalization of scientific drug regulatory in our country.Results In this study,we collected data from the domestic drug database of the State Food and Drug Administration,the accepted catalogue database of the State Food and Drug Administration and the relevant new drug approval database to make analysis,and study the status quo of the approval of innovative chemical drug production and marketing in China in combination with the annual review report released by the Drug Evaluation Center since 201 1.The analysis shows that the number of applications for clinical trials of new drugs,the approval rate of applications for clinical trials of new drugs,the number of applications for new drug production and marketing,and the approval rate of the applications for new drug production and marketing have all grown steadily in recent years.However,the result also intuitively reflects the continued decline of the quantity of new drugs approved for marketing and the approval rate.It is also summarized that there are four critical factors hindering the innovative drugs into marketing by analyzing the reason for disapprove,including the clinical trial protocol and result could not support this application for marketing,the standardability and authenticity of the application dossiers,the research of pharmacy is not sufficient and some policy against over list to marketing.In the meantime,according to the new drug registration to influence the outcome of risk factors analysis of questionnaire survey,which shows no matter in the study of new technology,or the establishment of the policy,are still need to improve,also confirmes the accuracy of the empirical research conclusion from a side.Conclusion Based on the research results of the empirical evidence,although in recent years,the national regulation level constantly push the new policy on the acceleration of the review and approval,but the overall evaluation of the operation situation of the review and approval system,compared with the purpose of this system designed,found that the current institutional system still cannot meet the demand of social objective,resulting in the current status of drug production listed registration in our country environment is serious.At the same time,considering the analysis of disapprove samples and questionnaire survey results,this paper comes up with the current drug approval and the problems existing in the listed drugs registration risks management in our country,putting forward to a package of reformation suggestions on optimizing innovative drug production for current registration situation,Such as strengthening communication mode of all the related parties,straightening the technical evaluation mechanism out,improving the affiliate approval system of active and non-active ingredient and strengthening pre-approval inspection for compliance of applying for marketing,etc.