Andersson F
MEDTAP Europe, Battelle Institute, London, England.
Int J Health Serv. 1992;22(1):53-72. doi: 10.2190/9Y32-X86Y-M3F0-JQFC.
This article reviews the literature related to the "drug lag" issue, i.e., the issue of whether important new drugs are introduced relatively late, or, in certain cases, are introduced at all, in a particular country. The literature can be divided into two main parts: studies primarily related to the delay in introduction of new drugs and studies primarily related to the number of introduced new drugs. Most studies have found the United States, Sweden, and Norway to have a long delay in the introduction of new drugs. The United Kingdom and (West) Germany in general have the shortest delay. There are also large differences in the number of introduced new drugs. In most studies, the United States and Norway have introduced far fewer new drugs than any other industrialized country. In general (West) Germany, France, the United Kingdom, and Italy have introduced the largest number of new drugs. One of the reviewed studies presented a relationship between regulatory processing time and delay in introduction. Another study found an increasing influence of regulatory stringency on the number of introduced new drugs in a country. If a country's aim is to decrease the delay in introduction and/or to increase the introduction of important new drugs, a review of the local regulatory agencies and the regulations seems worthwhile.
本文回顾了与“药物滞后”问题相关的文献，即重要新药在某一特定国家的引入是否相对较晚，或者在某些情况下根本未被引入的问题。这些文献可分为两个主要部分：主要与新药引入延迟相关的研究以及主要与引入新药数量相关的研究。大多数研究发现，美国、瑞典和挪威在新药引入方面存在较长延迟。英国和（西）德总体上延迟最短。在引入新药的数量上也存在很大差异。在大多数研究中，美国和挪威引入的新药比任何其他工业化国家都要少得多。总体而言，（西）德、法国、英国和意大利引入的新药数量最多。一篇被回顾的研究提出了监管审批时间与引入延迟之间的关系。另一项研究发现，监管严格程度对一个国家引入新药的数量影响越来越大。如果一个国家的目标是减少引入延迟和/或增加重要新药的引入，那么对当地监管机构和法规进行审查似乎是值得的。
