美国药物临床试验法律责任研究

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 424-429.

美国药物临床试验法律责任研究

孙宇昕¹, 魏芬芳^1,2, 杨悦^1,2*

1 沈阳药科大学工商管理学院,辽宁沈阳 110016;
2 国际食品药品政策与法律研究中心,辽宁沈阳 110016

收稿日期:2017-08-16 修回日期:2017-08-16 出版日期:2017-07-20 发布日期:2017-08-16
通讯作者: 杨悦,女,博士,教授,药事法规与药品政策。E-mail：yyue315@vip.216.com
作者简介:孙宇昕,女,在读硕士,药事管理。

Study on Legal Responsibility of Drug Clinical Trials in America

SUN Yu-xin¹, WEI Feng-fang^1,2, YANG Yue^1,2,*

1 College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
2 International Food and Drug Policy and Law Center, Liaoning Shenyang 110016, China

Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

摘要/Abstract

摘要： 目的深入分析美国食品药品监督管理局药物临床试验违法处罚制度,为完善我国药物临床试验法律责任制度提供依据。方法通过查阅中美法律法规与指南,结合案例,详细分析不同主体法律责任适用情形与处罚,并提出建议。结果美国临床试验法律制度明确规定了关键责任主体,包括申请人、研究人员、伦理委员会;法律依据充分且处罚严肃,一般对较轻微违规或造假行为采取信函沟通、资格罚以及延迟实质性审评;严重违法或造假行为人追究刑事责任。结论我国应识别关键责任主体,并完善责任主体法律责任,建立公开诚信的行业体系。对于轻微违规时与违规主体沟通有无,引导责任主体解决违规问题;加强黑名单制度与刑事处罚的有效衔接,推动严格刑事处罚的建立。

关键词: 临床试验, 责任主体, 法律责任, 刑事处罚

Abstract: Objective To conduct an in-depth analysis of drug clinical trial illegal punishment system in the United States, so as to perfect legal liability system of drug clinical trials in our country. Methods Through the review of the laws and regulations of the United States and the guidance of the law, the paper analyzed the applicable situation and punishment of different subjects' legal liability, and put forward some suggestions. Results The study found that the legal system of clinical trials in U S clearly stipulated the key responsible persons(RPs), including sponsors, investigators and IRBs. For minor violations or fraud, FDA usually communicates with RPs by letters, disqualification process or the AIP process. For serious criminal or counterfeiting will face withcriminal penalties. Conclusion China should identify the key responsible person, and promote the responsibility of RPs and establishment of readily accessible transparency system. Furthermore, we should guide RPs to solve minor problem by flexible communication process. The rigid criminal penalty system and the industry blacklist should be effectively established.

Key words: clinical trials, responsible person, legal liability, criminal penalty

中图分类号:

孙宇昕, 魏芬芳, 杨悦. 美国药物临床试验法律责任研究[J]. 中国药物警戒, 2017, 14(7): 424-429.

SUN Yu-xin, WEI Feng-fang, YANG Yue. Study on Legal Responsibility of Drug Clinical Trials in America[J]. Chinese Journal of Pharmacovigilance, 2017, 14(7): 424-429.

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