美国FDA发布的药物非临床研究警告信分析  

Analysis of U.S.Food and Drug Administration warning letters issued to non-clinical trial research

作　　者：梅妮 张皖晋 陈一飞 MEI Ni;ZHANG Wan-jin;CHEN Yi-fei(Shanghai Center for Drug Evaluation and Inspectioin,SHANGHAI 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《中国新药与临床杂志》2023年第6期406-410,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 对美国食品和药物管理局(FDA)发布的药物非临床研究警告信进行分析,为药物非临床研究质量管理规范(GLP)监管提供参考。方法 收集2008年至2022年FDA对非临床研究发出的警告信,统计警告信数量及问题分布情况,解析和归纳警告信中公布的研究者在非临床研究中发生的主要问题。结果 FDA对非临床研究发布的12封警告信中共有67项问题数,涉及21CFR58条款120项次。其中发生频率最高的缺陷是质量保证部门人员履职不足、专题负责人履职不足和研究过程中方案的实施及报告撰写。结论 FDA对药物非临床研究警告信中高频率问题集中于项目负责人及质量保证部门的履职尽责方面。监管机构应在人员的履职尽责方面重点关注,促进非临床研究质量的提升。AIM To analyze the non-clinical research warning letters issued by the U.S.Food and Drug Administration(FDA),and provide reference for non-clinical good laboratory practice(GLP)supervision.METHODS The warning letters issued by FDA for non-clinical researches from 2008 to 2022 were collected,the number of warning letters and the distribution of problems were counted,and the main problems of researchers in non-clinical researches published in the warning letters were analyzed and summarized.RESULTS Among the 12 warning letters issued by the FDA for non-clinical researches,there were a total of 67 question items,including 120 item times related to 21CFR58.Among them,the defects with the highest frequency were the insufficient performance of the personnel of the quality assurance department,the insufficient performance of the special subject leader and the defects of the standard operating procedures.CONCLUSION The high frequency of FDA's warning letters on non-clinical research focuses on the performance of the project leader and the quality assurance department.Regulatory agencies should focus on the performance of their duties to promote the quality of non-clinical research.

关 键 词：药物非临床研究质量管理规范 警告信 美国食品和药物管理局 研究人员 

分 类 号：R95[医药卫生—药学]