我国药物非临床安全性评价行业发展及监管现状  

Development and Regulatory Status of Non-Clinical Safety Evaluation Industry for Drugs in China

作　　者：谢寅[1] 刘晓萌[1] 张曦[1] 文海若 林志[1] 周晓冰[1] 耿兴超 XIE Yin;LIU Xiao-meng;ZHANG Xi;WEN Hai-ruo;LIN Zhi;ZHOU Xiao-bing;GENG Xing-chao(Institute for Safety Evaluation,National Institutes for Food and Drug Control(National Center for Drug Safety Evaluation and Monitoring);Institute for Biological Products Control,National Institutes for Food and Drug Control)

机构地区：[1]中国食品药品检定研究院安全评价研究所(国家药物安全评价监测中心) [2]中国食品药品检定研究院生物制品检定所

出　　处：《中国食品药品监管》2025年第2期36-43,共8页China Food & Drug Administration Magazine

摘　　要：为从源头保证药物安全性研究数据的质量,自20世纪90年代开始,我国逐步提出并建立了符合国际标准的药物非临床研究质量管理规范(GLP)及其认证检查制度。历经多年的发展,我国药物非临床安全性评价工作日臻规范,评价能力显著提升,已逐步与国际先进水平和标准接轨。本文梳理了我国药物GLP发展历程,并通过综合分析已获得国家药监局药物GLP资质的药物非临床安全评价机构的调查报告,总结了药物GLP机构的发展和运行现状,以及药物非临床安全性评价行业面临的挑战,以期为相关部门的科学监管工作提供思路,进一步规范我国药物GLP行业的发展,确保药品质量,推动药品研发的国际化进程。In order to ensure the quality of research data on drug safety research data from the outset beginning,since 1990s China began developing and implementing gradually proposed and established Good Laboratory Practice(GLP)standards for non-clinical drug research of drugs in the 1990s,aligning in line with international standards and establishing an its accreditation and inspection system.Over the past two decades,China’s non-clinical safety evaluation of drugs has become increasingly has implemented GLP in the field of drug non-clinical safety research for many years,and the work of drug non-clinical safety evaluation has been standardized,with significant improvements in and the evaluation capabilities ability,has been significantly improved,progressively integrating and it has gradually been in line with the international best practices advanced level and standards.This paper reviews the evolution development history of GLP in China and,through a comprehensive analysis of investigation reports from safety evaluation institutions accredited by the National Medical Products Administration(NMPA),summarizes the current development and operational status of GLP institutions,along with as well as the challenges faced by the industry and future prospects of the non-clinical safety evaluation industry by comprehensively analyzing the investigation reports of safety evaluation institutions that have obtained the GLP accreditation from the National Medical Product Administration(NMPA).The findings aim In order to provide insights for regulatory authorities to enhance recommendations on the scientific supervision of the competent administrative department,further standardize the development of China's drug GLP industry,ensure drug the quality of drugs,and promote the internationalization of drug research and development.

关 键 词：药物非临床安全性评价 药物非临床研究质量管理规范 新技术 监管 国际化 

分 类 号：R95[医药卫生—药学]