Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations
Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations
复制标题
DOI：
10.1111/j.1365-2710.2009.01099.x
复制
发表时间：
2010-06-01
影响因子：
2
通讯作者：
Tsutani, K.
中科院分区：
文献类型：
--
作者：
Tsuji, K.;Tsutani, K.
背景与目的：“药物滞后”是20世纪70年代和80年代在世界范围内备受争议的问题。由于公众对药物滞后的认识在日本是最近，这个问题还没有得到广泛的研究。因此，我们创建了一个数据库，新药批准在美国，欧盟（EU）和日本之间的1999年和2007年，并研究了药物滞后的情况，在这三个主要的医药markets.Methods：新药批准在美国，欧盟和日本之间的1999年和2007年确定了他们的国际非专利名称（INN），信息主要是从网站上收集的监管机构说，地区和“IMS R&D焦点”。在评估绝对药物滞后时，我们使用每个地区批准的药物数量和在研究期间三个地区批准的新药总数中的百分比作为变量。在评估相对药物滞后时，使用了两个变量;一个变量是各区域首次批准的数量和百分比，另一个变量是三个区域每种药物首次批准的批准滞后。亚组分析进行了根据发起人的国籍，原产地的物质（生物药品和非生物药品）和治疗group.Results和讨论：在398种新药，325（81中心点7%）被批准在美国，314（78中心点9%）在欧盟和220（55中心点3%）在日本。美国、欧盟和日本的中位批准延迟分别为0个月、2个中心点7个月和41个中心点0个月。虽然美国领先于其他两个地区，但美国和欧盟之间的差距很小。相反，在日本观察到了显著的药物滞后。美国（43个中心点，6%）和欧盟（56个中心点，1%）药物在日本的批准率均较低。与此同时，日本原产的药物在日本的批准率很高（94中心点5%）。据推测，非日本原产药物的新药申请延迟是日本药物滞后的主要原因。然而，批准的新药的百分比根据治疗组的不同，这意味着有不同的原因，在每个group.Conclusion药物滞后：本报告提供了一个全面的看法，在三个地区的药物滞后。需要进行更详细的分析，以便更深入地讨论药物滞后的背景因素、影响和措施，这在日本尤其明显。
P>Background and objective:'Drug lag' was a much-debated issue around the world during the 1970s and 1980s. Because public recognition of drug lag is recent in Japan, the issue has not been studied extensively. Therefore, we created a database of new drug approvals in the US, the European Union (EU) and Japan between 1999 and 2007 and examined the drug lag situation in these three major pharmaceutical markets.Methods:New drugs approved in the US, the EU and Japan between 1999 and 2007 were identified by their International Non-proprietary Names (INN), and information was gathered primarily from the websites of regulatory agencies of said regions and 'IMS R&D Focus'. In assessing absolute drug lag, we used as variables the number and the percentage of approved drugs in each region out of a total of new drugs approved either in the three regions in the study period. In assessing relative drug lag, two variables were used; one variable was the number and percentage of first approvals in the regions, and the other variable was the approval lag against the first approval granted to each drug in the three regions. Sub-group analyses were conducted according to the originator's nationality, the origin of the substance (biopharmaceuticals and non-biopharmaceuticals) and the therapeutic group.Results and discussion:Of the 398 new drugs, 325 (81 center dot 7%) were approved in the US, 314 (78 center dot 9%) in the EU and 220 (55 center dot 3%) in Japan. The median approval lag for the US, the EU and Japan was 0 months, 2 center dot 7 months and 41 center dot 0 months, respectively. Although the US was ahead of the other two regions, the difference between the US and the EU was small. On the contrary, a striking drug lag was observed for Japan. The approval rate in Japan was low for both the drugs of US origin (43 center dot 6%) and EU origin (56 center dot 1%). Meanwhile, the drugs of Japanese origin were approved at a high rate in Japan (94 center dot 5%). It was surmised that the delay in filing new drug applications for drugs of non-Japanese origin was the main reason for the drug lag in Japan. However, the percentage of approval of new drugs varied according to the therapeutic group, implying that there were different reasons for the drug lag in each group.Conclusion:This report provides a comprehensive view of drug lag in the three regions. More detailed analyses are necessary in order for a more in-depth discussion of the background factors, impacts and measures for the drug lag, which is especially noticeable in Japan.