新型冠状病毒肺炎公共卫生事件期间欧盟药品应急管理政策分析

新型冠状病毒肺炎（COVID-19）公共卫生事件,对满足公共卫生需求带来严重挑战。2020年7月,欧盟更新"COVID-19公共卫生事件期间的人用药品监管期望问答",完善了COVID-19防治用关键药品的行政许可、生产经营、监督检查、药物警戒和包装标签等系列应急管理措施,提出例外变更管理流程、远程评估、豁免检验、差异化不良反应报告制度等灵活监管策略,与药品生产经营企业共同维持药品供应链稳定,保障药品安全、有效、可及。了解欧盟药品应急管理政策,对完善我国药品应急管理体系具有参考价值。

Discussion on EU medicinal products regulatory expectations and flexibility during COVID-19 public health emergency

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.