欧美药典委员会利益冲突管理制度概况

Overview of management system for conflict of interest of the European Pharmacopoeia Commission and the United States Pharmacopoeia Convention

本文介绍了欧、美药典委员会关于利益冲突管理制度的概况。欧、美药典委员会在多个管理文件中(如:欧洲药典委员会工作指南、工作实施准则、利益声明和保密承诺表,美国药典委员会章程、专家委员会规则和程序、道德准则、行为标准手册),对药品标准工作中的利益冲突管理制度进行了规范,预期保证药品标准制定的透明度和公正性,提高药品标准的可信度和严谨性。本文通过介绍欧、美药典委员会利益冲突管理制度,为我国药典机构相关管理制度的完善提供参考。

This article introduces an overview of management system for conflict of interest of the European Pharmacopoeia Commission(EPC)and the United States Pharmacopoeia Convention(USP).The EPC and USP have standardized the management system for conflict of interest in drug standard work in multiple management documents,such as the Guide for the Work,Code of Practice for the Work,Form for Declaration of Interests and Confidentiality Undertaking of the EPC,bylaws,Rules and Procedures of the Council of Experts,Code of Ethics,Standards of Conduct of the USP,in order to ensure the transparency and fairness of drug standard development,improve the credibility and rigor of drug standards.This article introduces the management system for conflict of interest of the EPC and USP,providing reference for the improvement of relevant management systems of the Chinese Pharmacopoeia Commission.