药品人体试验法律问题分析-analysis of legal problems in human drug testing.docxVIP

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药品人体试验法律问题分析-analysis of legal problems in human drug testing.docx

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药品人体试验法律问题分析-analysis of legal problems in human drug testing

本文希望通过解决药品人体试验存在的问题，尽可能完善该制度，使使这项科学行为健康发展，最终造福于全人类。2 全文包括六部分：前言、正文共 4 章、结束语。前言部分介绍了“人体试验”的概念以及分类，并且对做为本文研究对象的“药品人体试验”的概念进行了描述，同时还对参与药品人体试验的主体进行了简要介绍。第一章主要阐述药品人体试验的一般理论；第二章主要阐述药品人体试验国内外立法状况；第三章主要阐述药品人体试验引发的法律问题及原因分析；第四章主要阐述如何完善我国的药品人体试验制度。关键词：药品人体试验；立法现状；监管；2李佳芳：人类辅助生殖技术之行政监管法律问题研究，广西大学硕士论文，2013 年。LEGAL ISSUES IN HUMAN DRUG TEST ABSTRACTIn modern times , with the development of biomedical knowledge and progress , human health protection and greatly improved, many previously incurable disease has been effective treatment and suppression , and human trials in which drugs played a great effect. In fact , human trials of drugs has long existed , but due to less exposure to make people forget its existence, until golden rice exposure incidents , human trials again into people s attention and cause great concern.As a developing country, the lack of concern for human trials, leading to inadequate legislation, regulation is not in place, for these reasons , there are many causes of legal problems in the course of conducting human trials of drugs , for example, the ethics committee access to medicines regulatory issues Construction of issues and subjects such as protection of the rights issue . The existence of these legal issues seriously hindered the healthy operation of human trials, and ultimately affect the development of human health. Therefore, to solve the legal problems that exist in human trials become extremely urgent.Because human trials in developed countries has a more long history , and its related legislation and supporting systems are more perfect , therefore , learn from foreign advanced practices and experiences to solve our problems in human trials of drugs is very helpful .Conduct human trials as a science , which in theory or practice of necessity very existence has , therefore adjust and improve the system of human trials seem promising important. This paper aims to solve the problems of human trials of drugs, as much as possible to improve the sys