The United States Registration And Approval System Of Generic Drug And Its Enlightenment To China

Since the 12 th Five Year Plan, the State Council has issued the "The Announcement on Serval Policy Advice Speeding up Solving the Backlog of Applications for Drug Registration", "the Advice for Reforming of Drug and Medical Device Review and Approval System", and the latter issued the approval marks of the drug review system reform started. The generic drugs played an irreplaceable role on the protection of citizens’ health in China, which is the largest producer of generic drugs and the government has accumulated some experience in the administration and approval of generic drugs, but the review and approval of how more standardized questions are faced. In the thirteenth Five-Year period, the drug regulatory authorities further plan and adjust the generic drug approval system scientifically and improve the scientific level of supervision, which is of great significance to promote the healthy development of the generic drug industry and public health services.This study was carried out the comparative study of Sino-US generic drug review and approval system by examining the similarities and differences between the two countries in the review and approval of generic drugs and the actual operation of the system to find the gap and to learn the practice and the reality of our country, proposed to further improve the generic drug review and approval during the institutional system Thirteen Five of China’s relevant suggestions and provide reference for improving policy more in line with national conditions and regulatory approval of generic drugs institutional system.The illustration, literature analysis, comparative analysis and other research methods, have been used in this study to ask, analyze and solve problems as the main line to study the differences between the generic drug review and approval system in two countries.The first chapter explained the basic situation such as the characteristics of the study object, the study background, the ideas and the methods. The second chapter expounded the current situation of the generic drug registration and approval system from the perspective of our generics industry development, elements of the approval system; The third chapter described the characteristics of the US generics review and approval more comprehensively in terms of the development process, rules and regulations, institutional settings, approval procedures of the institutional system The fourth chapter made a detailed comparative analysis of Sino-US generic drug registration system to identify gaps, similarities and differences; The fifth chapter proposed to further improve the generic approval system review recommendations, from the aspects of improving the access threshold for generic drugs to the market, establishing generic conformance assessment system to address the backlog of review and strengthen the technical review of capacity-building drugs, improving the transparency of registration and approval of generic drugs and the development of biological generic drug approval with the combination of the experience of United States and China’s practice.