新版《药物临床试验质量管理规范》下安全性报告伦理审查述要

新版《药物临床试验质量管理规范》在2020年颁布并实施,以充分贯彻落实中央《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》的精神,并适应人用药物注册技术要求国际协调会的规则。新版《药物临床试验质量管理规范》涉及伦理审查的重要更新之一在于,强调了申办者需要及时向伦理委员会提交可疑且非预期严重不良反应报告、其他潜在的严重安全性风险信息报告、研发期间安全性更新报告等安全性报告,对机构伦理审查能力提出了新的要求和挑战。作者结合欧盟、美国、英国等人用药物注册技术要求国际协调会成员国对安全性报告的伦理审查要求,探讨了我国在新形势下以注册为目的的药物临床试验安全性报告伦理审查的要点。

Discussion on the Key Points in Ethical Review of Safety Reports under the Newly Issued Good Clinical Practice

The new Good Clinical Practice is finally promulgated and implemented in 2020, which completely carried out the spirit of the State Council′s Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices,and also adapted to the rules and requirements of ICH. One of the important updates of the GCP involving ethical review emphasizes that the sponsor should submit safety reports to IRB timely, including suspected unexpected serious adverse reactions, other potential serious safety and risk information, development safety update report and other safety reports. It has brought new requirements and challenges for the ethical review ability of IRB. This paper will discuss the key points in ethical review of safety reports under the situations and circumstances in China,combining with the requirements of ethical review of safety reports of the European Union,United States,United Kingdom and other ICH members.