摘要
目的探讨我国在药品安全监管领域实施E2B(R3)后,对未来相关机构开展药物警戒以及药品不良反应监测与评价等药品安全工作的信息系统建设产生的影响。方法分析E2B(R3)实施的过程和范围,探讨实施E2B(R3)对我国药品监管机构、医疗机构、相关企业在各自信息系统建设过程中可能产生的影响和挑战。结果与结论 E2B(R3)的实施是我国药品安全监管领域的重要举措,其实施对我国药品监管机构、医疗机构、相关企业的信息系统建设都产生了系列挑战,各相关机构需要在总体规划、系统建设、标准兼容等多个方面采取相应的应对措施。
Objective To explore the impact of implementing E2B(R3) in the field of pharmaceutical supervision on the development of information systems for pharmacovigilance and ADR monitoring by related institutions in the future. Methods The process and scope of E2B(R3) implementation were analyzed, and the possible impact of E2B(R3) implementation on China’s regulatory bodies, medical institutions and related enterprises in the construction of their respective information systems was explored. Results & Conclusion The implementation of E2B(R3) is an important measure in the field of pharmaceutical supervision in China. It has posed a series of challenges to the information system construction of regulatory agencies, medical institutions and related enterprises. Those institutions need to take cor responding measures related to overall planning, system construction and standard compatibility.
作者
王青
任韡
杨吉江
WANG Qing;REN Wei;YANG Jijiang(Research Institute of Information Technology,Tsinghua University,Beijing 100084,China)
出处
《中国药物警戒》
2019年第10期591-593,601,共4页
Chinese Journal of Pharmacovigilance
基金
国家药品不良反应监测中心资助项目(2018IX001):E2B数据标准研究
