Courtney Brooke, Bond Katherine C, Maher Carmen
Biosecur Bioterror. 2014 Sep-Oct;12(5):239-46. doi: 10.1089/bsp.2014.0046.
In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.
2014年2月，来自世界各地的卫生官员宣布了全球卫生安全议程，这是一项至关重要的工作，旨在加强国家和全球系统，以预防、检测和应对传染病威胁，并促进更强有力的跨境合作。美国食品药品监督管理局（FDA）在确保医疗和食品产品的可及性、安全性和保障性方面，其全球角色日益增加且监管职责范围广泛，正在开展一系列支持全球卫生安全的工作。本文概述了FDA在全球卫生安全方面的作用，重点关注其在开发和使用医疗应对措施（MCMs）以预防、检测和应对全球传染病及其他公共卫生紧急威胁方面的职责。文章还讨论了几个领域——抗菌药物耐药性、食品安全和供应链完整性，在这些领域中，FDA在全球卫生安全方面的作用不断演变，并且超出了医疗应对措施的范畴，在某些情况下，还超出了传统传染病威胁的范畴。
