美国食品药品管理局信息化战略规划及启示

New Information Technology Strategic Plan from US FDA and its Enlightenment

本文研究了美国食品药品管理局(FDA)针对其信息化现状及面临的主要问题,如何从人员、流程、技术3个领域共20个方面对当前信息化战略进行改进,提出有针对性的解决措施,以应对监督管理科学创新以及日益艰巨的监管职责等诸方面的挑战,同时分析了FDA最新信息化战略给中国食品药品监督管理信息化工作的借鉴和参考。

Based on the current situation and the main problems faced by the US Food and Drug Administration （FDA）, this paper explored and analyzed that how FDA had put forward the new information technology strategic plan from the perspectives of the staff, processes and technologies, a total of 20 aspects, to improve its competence to deal with the challenges from the requirements for the inno- vation of regulatory science and the increasingly tough regulatory responsibilities. Meanwhile,the enlightenment and the reference value to the work of China FDA were also analyzed.