Analysis Of Current Situation Of Drug Clinical Trials In China

Clinical trials are necessary before new drugs going to market.In clinical trials on the human subjects, the researchers collected and analyzed safety and efficacy data of the drug, provide an important basis for drug approval.As a key link in the quality and safety of drugs, drug clinical trials have been the focus of attention of the government and the people.From the Ministry of Health for the first time in 1983 published 14 clinical pharmacology base, to today 572 drug clinical trial institutions and 3837 clinical trials,from the absence of special laws and regulations to the establishment of today, including the "drug clinical trial quality management practices", "Drug Registration Management", "Drug Clinical Trial Institutions Qualification Method(Trial)",China's drug clinical trial work has made gratifying achievements.But there have been a series of outstanding problems.In this paper,based the clinical trial data on-site verification results,we systematic analysis on the current situation of drug clinical trials in China find out the existing problems, put forward some thoughts and suggestions for the implementation of drug clinical trial in china.This paper mainly uses the data analysis method and the literature contrast analysis method. Based on the comparison and analysis of the similarities and differences between the GCP and ICH-GCP, the problems existing in the current drug clinical trials are analyzed and the deep reasons leading to these problems are searched.By comparing the revised version and the original version of the GCP, "drug clinical trial institutions management regulations" and "the draft of drug clinical trial institution identification measures(Trial)", summarizes the future trend of drug clinical trial supervision in China, finding a solution to the problem from the comparison results of GCP and ICH-GCP, put forward constructive suggestions for the improvement of clinical trials Chinese drugs.The results of the analysis show that there are some problems in clinical trials, such as regulatory system, sponsor / CRO, clinical trial institutions, researchers, ethics committee, subjects' protection and clinical trial expenses. China's pharmaceutical supervision and management departments are planning to start from the supervision system, and gradually clear division of responsibilities of all parties involved in the test, improve the clinical trial reporting system, detailed clinical trial regulations, and further strengthen the supervision and management of drug clinical trials.In view of the present situation, this paper argues thatthe state should gradually improve the regulatory system, explore the establishment of a new mode of clinical trial institution, promote the balanced development of drug clinical trial institutions, establish the GCP related knowledge training and exchange mechanism and subjects compensation mechanism, establish the regional ethics committee, accelerate the information construction to promote the rapid and healthy development of drug clinical trials in China.