2013年隨著歐盟《良好藥物警戒管理規(guī)范X》的生效，藥品額外監(jiān)測制度得到進一步完善。藥品額外監(jiān)測制度是一種通過建立監(jiān)測目錄、公開目錄藥品信息、采用特定標識等措施，鼓勵醫(yī)務人員和患者自發(fā)報告可疑不良反應，以便順利開展上市后安全性評價，確保任何新的用藥安全隱患能夠被及時發(fā)現(xiàn)和有效避免的制度。通過介紹歐盟藥物警戒額外監(jiān)測制度，闡述我國藥品不良反應（ADR）監(jiān)測的現(xiàn)狀，指出該制度是一種積極主動發(fā)現(xiàn)用藥風險的嘗試；學習和借鑒該制度，有助于我國彌補原有藥品ADR報告系統(tǒng)低報、漏報等缺陷，主動開展用藥安全監(jiān)測，從而獲得更加全面科學的結果。

With the entry into force of The Good Pharmacovigilance Practice module X in 2013, the pharmacovigilance additional monitoring system had been further consummated. Additional monitoring is a system that encourage reporting adverse reaction, enhance post-authorization data collection for medicine products and collect drug safety information as early as possible. The process of additional monitoring includes creation and maintenance of the list, making the related information publicly, and marking the certain symbol on the package leaflet. The aim of this article is to introduce the additional monitoring in European Union, expound the current status of adverse drug reaction (ADR) monitoring in China, and provide a reference for constituting the additional monitoring policy, in order to improve the reporting of ADR, strengthen the ADR monitoring system, thus to obtain the comprehensive and scientific results.