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自60年代初药物管理的新纪元开始以来,被批准上市的新药品种美国远较英国为少。作者通过比较两国因存在安全问题而淘汰的药物资料,考查了采用不同新药审批方针(如速度快慢、手续简繁等等)的相对安全性。有关最近20年间已淘汰的新老药物(新药为1964年或其后批准上市的;老药是1964年前批准上市的)列于表1。英美两国新药审批的手续不同,美国要求
Since the beginning of a new era of drug administration in the early 1960s, the number of new drug products approved for listing in the United States has been far smaller than in the United Kingdom. The authors examine the relative safety of different approaches to approval of new drugs (eg speed, simplicity of procedure, etc.) by comparing the drug data that have been phased out due to safety concerns in both countries. Table 1 lists the new and old drugs that have been phased out in the last two decades (the new drugs were approved for listing in 1964 or thereafter; the old drugs were approved for marketing before 1964). The procedures for approval of new drugs in Britain and the United States are different, the United States demands