中国食品药品监管Issue(2)：36-43,8.DOI:10.3969/j.issn.1673-5390.2025.02.003
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
谢寅 1刘晓萌 1张曦 1文海若 1林志 1周晓冰 1耿兴超2
作者信息
- 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
- 折叠
摘要
Abstract
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Key words
non-clinical safety evaluation of drugs/good laboratory practice/new technology/regulation/internationalization分类
药学引用本文复制引用
谢寅,刘晓萌,张曦,文海若,林志,周晓冰,耿兴超..我国药物非临床安全性评价行业发展及监管现状[J].中国食品药品监管,2025,(2):36-43,8.
