亚洲社会药学

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Discussion on Management of Expert Conflicts of Interest in Drug Evaluation Process

Chen Taohui 1, Zhang Xianglin 2*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Beijing Yeedozencom Healthcare Science &Technology Co.,Ltd., Beijing 100027, China
  • 出版日期:2016-09-20 发布日期:2016-11-21

Discussion on Management of Expert Conflicts of Interest in Drug Evaluation Process

Chen Taohui 1, Zhang Xianglin 2*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Beijing Yeedozencom Healthcare Science &Technology Co.,Ltd., Beijing 100027, China
  • Online:2016-09-20 Published:2016-11-21
  • Contact: Zhang Xianglin, guest professor, postgraduate tutor. Major research area: administration of drugs registration. Tel: 010-63365912, E-mail: zhang.xianglin@yahoo.com.cn.

摘要: Objective To explore the concept of expert conflicts of interest in drug evaluation process and the necessity to manage conflicts of interest, and to propose suggestions for regulating expert conflicts of interest in China by learning from experience of drug regulatory authorities in foreign countries. Methods Comparative method was used to study the management of expert conflicts of interest in drug evaluation process in Europe, the United States and China. Results and Conclusion FDA and EU attach great importance to the role of experts in drug evaluation process, and they also cope with the problems of expert conflicts of interest successfully. In contrast, there are some problems in drug evaluation process in China. Therefore, it is necessary to strengthen the transparency of evaluation process to avoid expert conflicts of interest and ensure the impartiality and scientific nature of their opinions.

关键词: American, EU, drug evaluation, expert, conflict of interest

Abstract: Objective To explore the concept of expert conflicts of interest in drug evaluation process and the necessity to manage conflicts of interest, and to propose suggestions for regulating expert conflicts of interest in China by learning from experience of drug regulatory authorities in foreign countries. Methods Comparative method was used to study the management of expert conflicts of interest in drug evaluation process in Europe, the United States and China. Results and Conclusion FDA and EU attach great importance to the role of experts in drug evaluation process, and they also cope with the problems of expert conflicts of interest successfully. In contrast, there are some problems in drug evaluation process in China. Therefore, it is necessary to strengthen the transparency of evaluation process to avoid expert conflicts of interest and ensure the impartiality and scientific nature of their opinions.

Key words: American, EU, drug evaluation, expert, conflict of interest