Kessler D A, Hass A E, Feiden K L, Lumpkin M, Temple R
Office of the Commissioner, Food and Drug Administration, Rockville, MD 20857, USA.
JAMA. 1996 Dec 11;276(22):1826-31.
In a study reported herein, the marketing approval dates of 214 drugs newly introduced into the world market from January 1990 through December 1994 were compared in 4 countries. The analysis reveals that the United States and the United Kingdom have similar patterns of drug availability, although the United States has a number of therapies with significant public health benefits that are not yet available in the United Kingdom. The findings also show that the United States outpaces both Germany and Japan in approving important new drugs. Various strategies adopted by the Food and Drug Administration to expedite its pharmaceutical review process, including the use of industry user fees, are described.
在本文所报道的一项研究中，对1990年1月至1994年12月新进入全球市场的214种药物在4个国家的上市批准日期进行了比较。分析显示，美国和英国的药品供应模式相似，尽管美国有一些对公共卫生有重大益处的疗法在英国尚未上市。研究结果还表明，美国在批准重要新药方面领先于德国和日本。文中描述了美国食品药品监督管理局为加快其药品审评过程所采取的各种策略，包括使用行业用户费。
