Study On Legal Supervision Of Drug Clinical Trial In China

As a highly specialized area, there is unknown to the human body risk. At the same time, the sponsor and the researcher may violate rules for the sake of their own economic interests, even ignore the security interests of subjects. Therefore, combing our country laws and regulations on drug clinical trial supervision, analyzing on the shortage of the drug clinical trial supervision in our country, and putting forward the improvement of the corresponding measures, which has very important practical significance to improve the relevant legal system of our country and strengthen the protection of the subjects.Paper is divided into three parts. The first part describes the concept of drug clinical trial supervision, economics foundations, legal values and basic principles. Drug clinical trial supervision as a form of government regulation, which refers to the drug regulatory agency to correct market failure and ensure citizen safety, according to the authorization of law, within the scope of their functions and powers, using of pharmaceutical affairs laws and regulations and policies and national drug standards for drug research and development process of drug clinical trials of intervention and control activities. Information asymmetry theory, market failure and government intervention are legal regulatory economics foundation of drug clinical trials. It is in the aspect of legal value should highlight the order value, human rights value and fair value. The basic principle of drug clinical trial supervision including subjects benefit first principle, respect the individual principle, proportion principle and scientific principle.The second part combs the legislative status quo in drug clinical trial supervision in China and analyzes its existence insufficiency. Due to the historical development of drug clinical trials relatively late in our country, although the legal supervision system has experienced from scratch never norms to regulate the process, it is still faced with many problems. Compared with the foreign developed areas, there are great gaps. The main problems include three aspects. Firstly, there are some disadvantages of the national regulatory authorities in drug clinical trials, including application approval time length, lack of communication mechanisms with the sponsor, the sponsor of the punitive measures against too light, provisions of the the researchers’obligation to inform is not perfect, no research financial terms of the provisions of the regulators, the lack of ethics committees regulatory norms. Secondly, the lack of independence of the ethics committee, is not conducive to play regulatory responsibilities of the Ethics Committee. Thirdly, the sponsor of the drug clinical trials regulatory norms imperfect. To make a standard drug clinical trial in our country, effectively ensure the legitimate rights and interests of the subjects, must be effective drug clinical trial, perfect the relevant laws and regulations. The last part of the paper puts forward the countermeasures of perfecting our country’s regulation in the drug clinical trials. First of all, for the national legal supervision of drug clinical trials, it should shorten the processing time, establish a communication mechanism conference to the sponsor, emphasis on the sponsor punishment measures, perfect researcher’s obligation to inform, establish a financial disclosure system, improvement of the ethics committee of regulatory norms; The next, the establishment of a regional ethics committee ensure the independence and impartiality; Finally, perfect sponsor of drug sponsor of drug clinical trial supervision and inspection system.