浅析国外药物警戒受权人制度对我国药品不良反应监测工作的启示

摘要

目的：简要介绍国外药品药物警戒受权人相关制度，为建立和完善我国药品不良反应监测联系人制度提供借鉴和参考。方法通过查阅国内外文献，应用文献研究的方法调研欧盟和澳大利亚的药物警戒受权人（QPPV）的相关制度，并进行分析。结果欧盟、澳大利亚均建立了严谨的药物警戒受权人制度，可为我国建立药品不良反应监测联系人制度提供宝贵的实践经验。结论吸收借鉴国际经验，结合我国的药品安全监管特点，应进一步建立和完善我国的药品不良反应监测联系人制度，提高药品不良反应监测水平。%Objective To provide suggestions for china to setup and improve the Contact Person of ADR through the brief introduction of Qualified Person for Pharmacovigilance (QPPV). Methods Based on literature review, the QPPV of EU and Australia was investigated and analyzed. Results QPPV has been set up in EU and Australia, it can provide valuable practical experience for our country to establish the Contact Person of ADR. Conclusion Combing with the feature of drug safety supervision in our country and using for reference of the international experience, we should establish and complete our country's Contact Person of ADR in order to improve the level of adverse drug reaction monitoring.