Investigational New Drugs https://doi.org/10.1007/s10637-018-0612-y PHASE III STUDIES The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States 1 2 2 Hiroki Nakayama & Naoki Matsumaru & Katsura Tsukamoto Received: 6 April 2018 /Accepted: 24 May 2018 Springer Science+Business Media, LLC, part of Springer Nature 2018 Summary The approval of orphan anticancer drugs in Japan has increased to meet high social demand. Drug lag, namely the approval lag of new drugs, is recognized as a social issue in Japan. We investigated the approval lag and its components, submission lag and review-time lag, between Japan and the United States (US) to reveal whether an approval lag still exists, and to identify potential factors that may contribute to reducing the approval lag. Anticancer drugs approved in Japan between April 2004 and November 2017 were investigated using publicly available information. Results showed that the median approval lag of orphan anticancer drugs in 2016–2017 was 727.0 days (interquartile range, IQR, 310.0–1054.3). The approval lag was significantly correlated with the submission lag (correlation coefficient = 1.00, P < 0.001) but not with the review-time lag (correlation coefficient = −0.16, P = 0.22). The submission lag was significantly longer
Investigational New Drugs – Springer Journals
Published: May 31, 2018
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