摘要
本文分析美国FDA外聘专家利益冲突声明制度,从利益冲突声明的主体、程序和主要内容等方面,对比分析美国FDA外聘专家利益冲突声明制度与我国的异同。我国药品监管部门虽然已经建立了外聘专家利益冲突声明制度,但相关规定分散在各个法规文件中,且不同单位外聘专家利益冲突声明的程序、主体、主要内容均不相同,缺乏规范化管理。国家药品监督管理局应成立专门的利益冲突审查委员会,并统一外聘专家利益冲突的声明程序、内容等,以确保外聘专家提供完整、客观的建议。
This paper analyzes the conflict of interest declaration system of FDA external experts from the aspects of the subject,procedure and main contents of the conflict of interest declaration.The similarities and differences between the United States and China are also compared and analyzed.Although the NMPA has established the conflict of interest declaration system for external experts,the relevant provisions are scattered in various legal documents.The procedures,subjects,and main contents of unites are all indicated different,lacking standardized management.It is suggested that the NMPA should establish a special conflict of interest review committee and unify the procedures and contents of the declaration of conflict of interest for external experts,for the benefit of external experts to provide a complete and objective advice.
作者
刘静文
张峥
董江萍
邢花
LIU Jing-wen;ZHANG Zheng;DONG Jiang-ping;XING Hua(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110000,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100032,China;China Center for Food and Drug International Exchange,Beijing 100000,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第7期638-643,共6页
Chinese Journal of New Drugs
关键词
外聘专家
利益冲突
经济利益
财务披露
制度
external expert
conflict of interest
economic interest
financial disclosure
system
