新型冠狀病毒肺炎（COVID-19）公共衛(wèi)生事件，對(duì)滿足公共衛(wèi)生需求帶來嚴(yán)重挑戰(zhàn)。2020年7月，歐盟更新"COVID-19公共衛(wèi)生事件期間的人用藥品監(jiān)管期望問答"，完善了COVID-19防治用關(guān)鍵藥品的行政許可、生產(chǎn)經(jīng)營、監(jiān)督檢查、藥物警戒和包裝標(biāo)簽等系列應(yīng)急管理措施，提出例外變更管理流程、遠(yuǎn)程評(píng)估、豁免檢驗(yàn)、差異化不良反應(yīng)報(bào)告制度等靈活監(jiān)管策略，與藥品生產(chǎn)經(jīng)營企業(yè)共同維持藥品供應(yīng)鏈穩(wěn)定，保障藥品安全、有效、可及。了解歐盟藥品應(yīng)急管理政策，對(duì)完善我國藥品應(yīng)急管理體系具有參考價(jià)值。

The current Coronavirus Disease 2019 (COVID-19) public health crisis is posing unprecedented challenges on public health needs of European Union (EU). EU has updated Questions and Answers on Regulatory Expectations for Medicinal Products for human use during the COVID-19 Pandemic in July 2020, adjusted the regulatory expectations and flexibility related to marketing authorization, inspection, pharmacovigilance activities, products information and labelling, etc, during COVID-19 pandemic, articulated series of appropriate measures and provided flexibility legal tools such as exceptional change management process, distant assessment, postponing the testing, prioritisation of pharmacovigilance activities, to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic, ensure the high standards of quality, safety, efficacy of medicines, and availability of medicinal products. The emergency management experience of EU was still useful for perfecting the drug emergency management system of China.