Drug clinical trials play an important role in the course of drug development.The outcome of clinical trials is crucial to evaluate the safety and efficacy of drugs.On the basis of literature research,interviews with the experts and comparison with American system,the report first clarifies the legal system and requirements,showing the status quo of the drug clinical trials implementation in China by charts and statistics.Through analyzing the problems existed in the implementation and oversight,the report provides some feasible suggestions to perfect the regulatory system of drug clinical trials by two angles,which aim to provide decision-making reference for the drug registration review system innovation,to promote the new drug research,and to protect the safety and rights for the subjects. <<