全例調査に係る承認条件の現状とその付与に影響を与える因子についての検討

抄録

In Japan, with the increasing use of overseas clinical data in clinical data packages submitted for new drug application, the amount of Japanese clinical data used in new drug application has been decreasing. Reports have shown that all-case surveillance studies have been conducted for a relatively large number of new drugs approved recently. While surveillance studies serve as one of the useful tools in the monitoring of postmarketing safety, all-case surveillance studies impose an additional burden on pharmaceutical companies and medical institutions. Therefore, their operation has to be improved. With this background, we examined the recent status of all-case surveillance study in Japan and factors influencing the judgment of its necessity. Eighty-two of 261 new drugs approved between 2006 and 2013 were required to conduct all-case surveillance studies for a certain period after launching. Orphan drugs and antineoplastic agents account for a large proportion of these drugs. Significant safety concern is considered to be a factor necessitating the conduct of all-case surveillance study. Also, accumulation of safety data on previously approved similar drugs and comparability of the new drug with the preceding drugs affect the judgment on the necessity of all-case surveillance study.