我国药物临床试验法律监管研究

发布时间：2018-05-27 12:42

本文选题：药物临床试验 + 法律监管　；参考：《福州大学》2014年硕士论文

【摘要】：药物临床试验作为一个高度专业化的领域,对人体存在未知的风险性,同时,试验的申办者和研究者可能为了自身的经济利益而违规操作甚至忽视受试者的安全利益。因此,梳理我国有关药物临床试验监管的法律法规,分析我国有关药物临床试验监管的不足并提出相应的完善措施,对于健全我国的相关法律制度、加强对受试者的权益保护都具有非常重要的现实意义。论文共分为三部分。第一部分介绍了药物临床试验法律监管的概念、经济学基础、法律价值和基本原则。药物临床试验法律监管作为政府监管的一种,是指药品监督管理部门为矫正市场失灵、保障公民用药安全,依据法律的授权,在职权范围内,运用药事法律法规和政策、国家药品标准对药品研发过程进行的药物临床试验采取的干预和控制的活动。信息不对称理论、市场失灵与政府干预理论是药物临床试验法律监管的经济学基础。药物临床试验法律监管在法律价值方面应突出秩序价值、人权价值和公平价值,其基本原则包括受试者利益第一原则,尊重个人原则,比例原则和科学性原则四个方面。第二部分梳理我国对药物临床试验监管的立法现状并剖析其存在的不足。由于我国药物临床试验的历史发展较晚,虽然法律监管制度经历了从无到有、从不规范到规范的过程,但是仍面临着不少问题,与国外发达地区相比,还存在很大的差距。存在的问题主要包括三大方面,一是国家监管部门对药物临床试验监管存在缺陷,包括申请审批时限长；缺乏与申办者的交流机制,对申办者的处罚措施过轻,没有对研究机构和研究者财务方面的监管规定,缺少对伦理委员会的监管规范。二是伦理委员会缺乏独立性,不利于发挥伦理委员会的监管职责；三是申办者对药物临床试验的监管规范不完善。‘要想使我国药物临床试验规范有序的进行,受试者的合法权益得到有效保障,就必须有效监管药物临床试验,完善相关的法律法规。论文的最后一部分提出了完善我国药物临床试验法律监管的对策措施,首先,对于国家对药物临床试验法律监管而言,应缩短审批时间,建立与申办者的会议沟通机制,加重对申办者的处罚措施,完善对研究者告知义务和财务状况的监管,建立伦理委员会的注册认证制度和跟踪审查制度；其次,建立区域性伦理委员会,保证伦理委员会的独立性和公正性；最后,完善申办者对药物临床试验的监查和稽查制度。
[Abstract]:As a highly specialized field, drug clinical trials have unknown risks to human body. At the same time, the applicants and researchers may violate the rules and even ignore the safety interests of the subjects for the sake of their own economic interests. Therefore, by combing the laws and regulations concerning the supervision of clinical trials of drugs in China, analyzing the deficiencies of the supervision of clinical trials of drugs in China and putting forward corresponding measures to improve the relevant legal system of our country, It is of great practical significance to strengthen the protection of the rights and interests of the subjects. The paper is divided into three parts. The first part introduces the concept, economic basis, legal value and basic principles of legal supervision of drug clinical trials. As a kind of government supervision, the legal supervision of drug clinical trials refers to the application of pharmaceutical laws, regulations and policies by drug regulatory departments in order to correct market failures and ensure the safety of drug use by citizens, in accordance with the authorization of the law and within the scope of their functions and powers. National Drug Standards intervention and control activities for drug clinical trials conducted during drug development. The theory of information asymmetry, market failure and government intervention is the economic basis of the legal supervision of drug clinical trials. The legal supervision of drug clinical trial should emphasize the value of order, human rights and fairness in the aspect of legal value. Its basic principles include the principle of subject interests first, the principle of respecting individual, the principle of proportion and the principle of science. The second part combs the current situation of our country's legislation on the supervision of drug clinical trials and analyzes its shortcomings. Because of the late development of the history of drug clinical trial in our country, although the legal supervision system has experienced the process from nothing to existence, from non-standard to standard, it still faces many problems, and there is still a big gap compared with the developed regions abroad. The existing problems mainly include three major aspects: first, the state regulatory authorities have defects in the supervision of clinical trials of drugs, including the long time limit for application and approval; the lack of communication mechanism with the applicants; and the lenient punishment measures imposed on the applicants. There are no financial regulations for research institutions and researchers, and no regulation for ethics committees. The second is the lack of independence of the ethics committee, which is not conducive to giving full play to the supervision function of the ethics committee; the third is the imperfect regulatory norms of the applicant for the clinical trial of drugs. If we want to make the clinical trials of drugs in our country carry out in an orderly manner and ensure the legal rights and interests of the subjects, we must effectively supervise the clinical trials of drugs and perfect the relevant laws and regulations. In the last part of the paper, the author puts forward the countermeasures to improve the legal supervision of drug clinical trials in China. Firstly, the examination and approval time should be shortened and the meeting communication mechanism should be set up with the applicants for the legal supervision of drug clinical trials. To increase the penalty measures for the applicants, to improve the supervision of the researcher's obligation to inform and the financial situation, to establish the registration and certification system of the ethics committee and the tracking and examination system; secondly, to establish the regional ethics committee. To ensure the independence and impartiality of the ethics committee; finally, to improve the monitoring and inspection system of drug clinical trials.
【学位授予单位】：福州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

【相似文献】