A Comparison Of Generic Registration Administration Between China And USA

By comparing the speed,quality and quantity of generic drugs of Chinese and American,to learn the different situation of generic drugs between the two countries.Then identify and analyze all factors that may affect the quality,the speed of evaluation and R&D in each country,the factors including review and approval agencies,processes,models,R&D requirements,guidance,communication,and incentive policies,post-marketing management,and so on.At the same time,the current pharmaceutical reform was analyzed and evaluated in order to provide some thoughts for further reform.Since 2015 China's pharmaceutical reforms began,the situation has changed a lot and the studies in the past are inappropriate to the future.This paper focused on the analysis of effect of domestic generic drugs after the 2015 reform,which is more time-efficient.Secondly,we can conduct 2 conclusions by analysis of the current situation of China.On one hand,there are few excellent products to meet the requirements although the big scale of generic drugs.On the other,the speed of development of generic drugs is fast,but the quality needs to be improved.China should learn from America not just copy but base on China's objective national conditions.Finally,the research method of this paper is to find out the possible factors that affecting the speed and quality of the review,and then analyze and study these factors.This is the improvement comparing with the past articles.Comparative analysis and regulatory literature research methods are applied in this paper.The legal literature analysis method is applied to elaborate the regulatory system for the registration of generic drugs in China and the United States.The comparative analysis method is applied to compare and analyze the specific factors of the two countries to understand the differences between China and the United States.