The Health Care Science Institute, Tokyo, Japan.
J Clin Pharm Ther. 2010 Jun;35(3):289-301. doi: 10.1111/j.1365-2710.2009.01099.x.
'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.
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.
Of the 398 new drugs, 325 (81.7%) were approved in the US, 314 (78.9%) in the EU and 220 (55.3%) in Japan. The median approval lag for the US, the EU and Japan was 0 months, 2.7 months and 41.0 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 (43.6%) and EU origin (56.1%). Meanwhile, the drugs of Japanese origin were approved at a high rate in Japan (94.5%). 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.
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.
“药品滞后”在 20 世纪 70 年代和 80 年代曾是全世界热议的话题。由于日本公众对药品滞后的认识较晚，因此该问题尚未得到广泛研究。因此，我们创建了一个涵盖 1999 年至 2007 年期间美国、欧盟（EU）和日本新药批准的数据库，并研究了这三个主要制药市场的药品滞后情况。
通过药品的国际非专利名称（INN）确定了 1999 年至 2007 年期间在美国、欧盟和日本获得批准的新药，并主要从上述地区监管机构的网站和“IMS R&D Focus”收集信息。在评估绝对药品滞后时，我们将各地区批准的新药总数除以该地区批准的新药总数，以此作为评估变量。在评估相对药品滞后时，我们使用了两个变量：一个变量是各地区首次批准的新药数量和比例，另一个变量是各地区新药批准相对于三种地区中每种新药首次批准的滞后时间。根据原研药国籍、物质来源（生物制药和非生物制药）和治疗组别进行了亚组分析。
在 398 种新药中，美国批准了 325 种（81.7%），欧盟批准了 314 种（78.9%），日本批准了 220 种（55.3%）。美国、欧盟和日本的中位批准滞后时间分别为 0 个月、2.7 个月和 41.0 个月。虽然美国领先于其他两个地区，但两者之间的差距较小。相比之下，日本的药品滞后现象非常明显。来自美国和欧盟的药品在日本的批准率较低（分别为 43.6%和 56.1%）。而日本原产药品在日本的批准率较高（94.5%）。推测非日本原产药品新药申请延迟是日本药品滞后的主要原因。但是，根据治疗组别，新药的批准率存在差异，这表明每个组别出现药品滞后的原因不同。
本报告全面阐述了这三个地区的药品滞后情况。为了更深入地讨论药品滞后问题，包括日本的药品滞后问题，还需要进行更详细的分析。
