美国FDA药物临床试验研发主体合规检查信息公开情况的介绍和启示
Introduction to FDA's disclosure of compliance inspection information of research and development entities of drug clinical trials and its implication for China
刘艺迪 1何辉 1周刚1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
美国FDA在药物临床试验研发主体合规检查信息的公开及数据库建设方面有着较为成熟的经验.本文对美国FDA管理和公开药物临床试验研发主体合规检查信息的方式进行系统介绍,并结合我国监管现状,为我国药品监管部门建立规范化的合规检查信息数据库、提高药物临床试验研发主体合规检查信息的可及性提出建议.
Abstract
The Food and Drug Administration(FDA)of the United States has mature experience in the disclosure of compliance inspection information and database construction for research and development entities of drug clinical trials.This article provides a systematic introduction to this system of FDA.Based on the current regulatory status in China,suggestions were proposed for the drug regulatory authorities to establish a standardized compliance inspection information database and improve the accessibility of compliance inspection information of research and development entities of drug clinical trials.
关键词
药物临床试验/合规检查/临床研究者/药物临床试验机构Key words
drug clinical trial/compliance inspection/clinical investigator/drug clinical institute引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据