基于新修订《药品管理法》背景下的药物临床试验标准操作规程探讨  

Discussion on Standard Operating Procedures of Clinical Trials of Drugs According to the New Edition of Drug Administration Law

作　　者：邹宇玲[1] 王雅雯[1] 郑丽娥[1] 范玉明[1] 高泽诚 Zuo Yuling;Wang Yawen;Zheng Li'e;Fan Yuming;Gao Zecheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药事》2019年第12期1400-1405,共6页Chinese Pharmaceutical Affairs

摘　　要：新修订《中华人民共和国药品管理法》(以下简称《药品管理法》)提出了药物临床试验应该遵守由国务院药品监督管理部门会同国务院有关部门制定的药物临床试验质量管理规范;以保证药物临床试验的规范性、结果科学、可靠性、完整性及可信性,以及保证受试者的权益和安全;为了遵守新法规要求,本文探讨了基于新修订《药品管理法》背景下,如何制定药物临床试验标准操作规程(SOP)的方法、制定SOP的范围,如何管理SOP、如何培训和审查SOP等,为新法规实施细则的制定提供参考。The new edition of the Drug Administration Law of the People’s Republic of China(hereinafter referred to as the"Drug Administration Law")proposes that clinical trials of drugs should comply with the Good Clinical Practices(GCP)formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council so as to ensure the standardization,scientificity,reliability,integrity and credibility of clinical trials of drugs and to ensure the rights and safety of subjects.In order to comply with the requirements of the new law,authors of the paper discuss how to formulate standard operating procedure(SOP)for clinical trials of drugs,the scope of SOP,how to manage SOP,how to train and review SOP,etc.according to the new edition of the Drug Administration Law in order to provide references for developing rules of implementation for the new law.

关 键 词：药物临床试验 标准操作规程 审查 修订 

分 类 号：R95[医药卫生—药学]