醫(yī)學(xué)文獻(xiàn)監(jiān)測(cè)指在一定范圍內(nèi)，收集、評(píng)估并上報(bào)待監(jiān)測(cè)活性物質(zhì)的不良反應(yīng)報(bào)告，以提高上報(bào)不良反應(yīng)報(bào)告的效率與質(zhì)量，是藥品不良反應(yīng)（adverse drug reaction，ADR）管理和報(bào)告的重要環(huán)節(jié)。歐洲藥品管理局（EuropeanMedicines Agency，EMA）是最早開展醫(yī)學(xué)文獻(xiàn)監(jiān)測(cè)的機(jī)構(gòu)之一，現(xiàn)已建立了較規(guī)范的醫(yī)學(xué)文獻(xiàn)監(jiān)測(cè)方案和較為成熟的評(píng)估體系。通過(guò)介紹分析EMA醫(yī)學(xué)文獻(xiàn)監(jiān)測(cè)體系，并結(jié)合我國(guó)ADR監(jiān)測(cè)現(xiàn)狀與存在的問(wèn)題，從制定監(jiān)測(cè)技術(shù)指南與質(zhì)量管理規(guī)范、推動(dòng)不良反應(yīng)信息公開等方面提出政策建議，為健全ADR監(jiān)測(cè)體系提供參考。

Medical literature monitoring (MLM) refers to screening, processing and reporting active substances that are monitored in a certain range to improve the efficiency and quality of ADR reports, which closely connect ADR management and reporting process. European Medicines Agency (EMA) is one of the first institutions to monitor the medical literature. After continuous exploration and reform, a standardized scheme and mature MLM evaluation system has been established. With the introduction and analysis of MLM system, combining with the current situation and existing problems of it in China, this paper puts forward policy suggestions in several aspects, such as formulating supporting technical guidelines to standardize monitoring details of each step, formulating MLM quality management standards to strengthen the supervising process, and promoting the disclosure of adverse reaction information to improve data sharing mechanism.

R951

國(guó)家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項(xiàng)（201507004）；國(guó)家食品藥品監(jiān)督管理總局保健食品審評(píng)中心保健食品原料目錄研究專項(xiàng)課題（ZBW-2017-BJSP-10）