医药产品紧急使用授权

摘要

The Emergency Use Authorization (EUA) is an authorization by the Food and Drug Administration (FDA) for the use of medical products, i. e. , an unapproved product or for the unapproved use of an approved product, when an emergency or a potential emergency exists. The background and legal bases for the EUA, the role of the EUA as a mission of the FDA, the procedures of the review, issuing, termination of the EUA are studied, and the successful experiences in responding to the 2009 H1N1 influenza pandemic and the challenges are analyzed. The emergency authorization of ArepanrixTM A/H1N1 vaccine and Novartis H1N1 vaccine in Japan in 2009 is also analyzed comparatively.%医药产品紧急使用授权(Emergency Use Authorization,EUA)指由美国食品药品管理局(FDA)在实际的或潜在的紧急状态下对未获批准的医药产品的使用及已获批准产品的未获批准用途的授权.本文结合实际操作层面,对EUA的法律基础、EUA在FDA使命范围内的作用、EUA的审评、发布和终止程序、应对2009年H1N1流感取得的成功经验以及EUA实施过程中遇到的挑战进行分析.同时与日本应对2009年H1N1大流行时对ArepanrixTM A/H1N1流感疫苗和Novartis H1N1流感疫苗的紧急授权进行比较分析.