Comparative Study On Management System For Drug Registration Of American, European And China

Drug registration is performed by the department of drug registration management to give a judgment that whether or not a drug will be permitted to be marketed. This permission is based on the evaluation of safety, efficacy and quality control. Drug registration also reviews the outcome of drug development items that have characteristics of long periodicity, large investment and high risk. Therefore, management system of drug registration not only influences motivation and efficacy of drug development, but also is an important drug supervision link which has a close relationship with the safety and efficacy of medicine use.At first, this paper describes the four stages that China drug approval application undergoes, and analyzes the present situation of management system of drug registration of China. A drug evaluation mechanism of China goes more and deeper into transformation, especially after China’s entry into WTO in2001. New situation brings on both opportunities and challenges which make a strong impact on the innovation of management system of drug registration of China, and further advance the promotion and internationalization of the system. However, with development of technology and requirement of health, some defects are shown in drug approval application process. Afterward, this paper expatiates and appraises the main problems of management system of drug registration of China now. Finally, to solve the problems mentioned above, some alternative measures were provided, including making the progress of rules and regulatory&scientific guides of drug registration, solving the new problems result in drug registration reform, and regulating the supervisory method to promote drug registration and drug supervision in China.