Current Situation,problems And Countermeasures Of The New Drug Evaluation Policy Implementation In China

The development and marketing of new drugs is a sign of the comprehensive level of national medical science and technology and an important means to improve the medical level of a country.As the last pass for a new drug to enter the market,drug review is responsible for the major mission of ensuring that drugs are safe,effective,and quality controllable.In recent years,the state has adopted a series of reforms to the drug review and approval system to encourage the innovative research and development of drugs that are urgently needed in clinical practice and speed up the market.This article takes the new drug review policies and processes as the object,discusses its existing problems,and proposes improvement measures.This article discusses the related issues of the new drug review system through the literature method,questionnaire survey method,interview method,and the Smith model theory,including the following aspects.First,this article describes the topic selection background and research significance of the new drug review policy as the theme of the thesis,and reviews the research on drug review policy by domestic and foreign scholars.Second,based on the analysis of the development history of new drug approval,this article focuses on the new drug review basis laws and regulations,the development status of the new drug industry,the status of the drug review center responsible for new drug review,and our country’s new drug registration review policy process and policies.The current situation of the new drug review policy is analyzed.Subsequently,through questionnaire surveys,interviews and other methods,it was learned that in the implementation of our country’s new drug review policy,the cooperation mechanism between various departments has not yet been formed,the quality of the application materials is uneven,the interaction with the industry is not enough,the communication platform needs to be improved,and the degree of informatization needs to be strengthened.There are problems with the establishment of the organization and the staff,and the review basis system needs to be further improved.In response to existing problems,this article is based on the Smith process theory of policy implementation,and analyzes the reasons for its emergence from the four dimensions of policy itself,executors,target groups,and policy environment.These reasons include the late start of my country’s new drug market,which is not yet mature,and my country’s Drug review policies need to continue to run-in,the development of review teams is affected by factors such as establishment,and the rapid development of the industry has led to uneven quality of employees.In this regard,it is proposed to increase industry innovation,optimize review and approval systems,and improve the talent team.Countermeasures and suggestions for corporate responsibility.Our country attaches great importance to the review of drugs and proposes that during the "14th Five-Year Plan" period,the rapid review and approval mechanism for innovative drugs,vaccines,and medical devices will be further improved,and the review and approval of drugs and medical devices for urgent clinical needs and rare diseases and medical devices will be accelerated.To promote the clinical urgent need for new drugs and medical devices that have been marketed overseas to be listed in China as soon as possible.This article provides reasonable suggestions for enhancing the scientificity and rationality of the new drug review policy,improving the policy implementation mechanism,and creating a good policy implementation environment.