我国临床试验期间药物警戒工作实践与思考

The practice and consideration of pharmacovigilance during clinical trials in China

目的对比美国与欧盟药物警戒建设,尤其是安全信号的监测与管理,思考我国临床试验期间药物警戒的未来发展方向。方法梳理对比美国与欧盟实施药物警戒的组织框架、法律法规体系、安全信号的概念与管理,结合我国相关工作的实施经验,提出提高我国临床试验期间药物警戒水平的建议。结果与结论美国与欧盟药物警戒体系较为完善,安全信息监测与风险管理机制相对成熟。我国临床试验药物警戒体系已逐步建立,可借鉴国外经验,通过健全法律法规与组织体系、开展重点监测,以及提高信息化水平等多举措提高我国临床试验药物警戒水平。

Objective To compare the construction of pharmacovigilance between United States and European Union,especially on the monitoring and managing of the safety signal;to meditating the future development direction of pharmacovigilance of China during the clinical trial.Methods The organizational framework,law and regulation system,the concept and management of safety signal for the implementation of pharmacovigilance between United States and European Union were compared,combined with the implementation experience of relevant work in China,suggestions for improving the level of pharmacovigilance during clinical trials in China were put forward.Results and Conclusion The pharmacovigilance system of United States and European Union are relatively perfect,the monitoring of safety information and mechanism of risk management are relatively mature.The pharmacovigilance system of clinical trial of China has been basically in place.The advance foreign experience can be referenced and through strengthening the law and regulation and organization system,carrying out focusing monitoring to improve the level of informationization to improve the level of pharmacovigilance of clinical trial in China.