完善我国药品试验数据保护制度的相关建议

Suggestions on improving the protection system of drug test data in China

目的为我国药品试验数据保护制度的完善提供建议。方法通过梳理我国药品试验数据保护制度发展历程,与美国药品试验数据保护制度进行对比,提出我国药品试验数据保护制度存在问题及完善建议。结果与结论我国药品试验数据保护制度执行细节、与新颁布法规之间链接、信息公开渠道和制度有待完善,美国等发达国家药品试验数据保护制度实施经验教训值得我们借鉴和参考。

Objective To provide suggestions for the improvement of drug test data protection system in China.Methods By combing the development of the data protection system of drug test in China and comparing it with the data protection system of drug test in America,this paper puts forward some problems and suggestions.Results and Conclusions The implementation details,links to the newly issued regulations,information disclosure channels and systems of China's drug test data protection system need to be improved,the experience and lessons of the implementation of drug test data protection system in developed countries such as the United States are worthy of our reference.