Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations

Abstract

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 (81.7%) 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.

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.