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Legal Issues In Human Drug Test

Posted on:2015-04-24Degree:MasterType:Thesis
Country:ChinaCandidate:N DuFull Text:PDF
GTID:2296330431989479Subject:Constitution and Administrative Law
Abstract/Summary:PDF Full Text Request
In 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 system so that the healthy development of behavioral science to make this the ultimate benefit of all mankind.Paper includes six parts:introduction, body4, Conclusion.The preface introduces the " human testing " concept and classification, and the concept of" human trials of drugs," the object of this study as has been described, but also on the subject of human trials of drugs involved in a brief introduction. Foreword part has been clear about the concept and classification of the "human test", and as the research object in this paper the concept of "drug trials" are described, and also to human trials of medicines and the main body involved are introduced.Chapter Ⅰ describes the general theory of human trials of drugs;Chapter Ⅱ describes the legislative status of human trials of drugs at home and abroad;Chapter Ⅲ describes the legal issues raised human trials of drugs;Chapter Ⅳ describes how to strengthen human trials of drugs improve our system.
Keywords/Search Tags:Drug human trials, legislative status quo, supervision
PDF Full Text Request
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