摘要
临床质量管理规范(GCP)是重要的国际协调会议(ICH)一级指导原则。本文结合ICH管委会成员国药物临床试验质量管理规范相关法规,概述了GCP的相关法律框架,探讨了ICH-E6与GCP的关系,并总结了欧盟、美国和日本的GCP特色要求。对于实施默示许可制的我国来说,借鉴欧美临床试验暂停和提前终止管理要求的先进相关经验,将在提高审评效率同时有效的控制风险。为欧美日GCP相较于ICHGCP特色的要求更细化、更强化的体现了GCP对受试者的保护和数据可靠性的保证,同时又兼顾了本国的国情和相关法规的兼容性,是十分值得我国GCP借鉴的,建议随着我国临床试验监管科学的不断发展,逐步推进完备的临床试验管理法律体系的建立。
Good Clinical Practice(GCP)is an important guiding principle in International Council for Harmonization(ICH).This paper summarizes the relevant legal framework of GCP,discusses the relationship between ICH-E6 and GCP,and summarizes the characteristic requirements of GCP in the European Union,the United States and Japan based on the relevant regulations of the QUALITY management standards for drug clinical trials of member states of THE ICH Administrative Committee.For Our country implementing the implied licensing system,drawing on the advanced relevant experience of the European and American clinical trial suspension and early termination management requirements will improve the evaluation efficiency and effectively control the risk.For Europe and the United States,GCP compared with,for example-the characteristics of GCP requirements more refinement strengthening embodies the GCP the protection of the subjects and the guarantee of data reliability,at the same time,both the country's state of the compatibility and related laws and regulations,it is very worthy of GCP for reference in our country,suggested that with the continuous development of our country clinical trials regulatory science,gradually promote the establishment of a complete clinical trial management legal system.
作者
苏娴
SU Xian(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国医药科学》
2020年第24期251-253,共3页
China Medicine And Pharmacy
