首页|美国FDA外聘专家利益冲突声明制度对我国的启示

美国FDA外聘专家利益冲突声明制度对我国的启示

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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.
The conflict of interest declaration system of FDA external experts:The inspiration for China
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.

external expertconflict of interesteconomic interestfinancial disclosuresystem

刘静文、张峥、董江萍、邢花

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沈阳药科大学工商管理学院,沈阳 110000

国家药品监督管理局食品药品审核查验中心,北京 100032

中国食品药品国际交流中心,北京 100000

外聘专家 利益冲突 经济利益 财务披露 制度

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(7)
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