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Analysis of Drug Lags and Designation Lags of Orphan Drugs Recently Approved in Japan
2016
Regulatory Science of Medical Products
This study aims to understand the current situation and discuss elements that would further promote the development of orphan drugs in Japan. We analyzed drug lags(approval lags)and designation lags on orphan drugs approved as new drug categories in Japan over the past 5 years from 2010 to 2014. As a result, many of orphan drugs were developed in Japan after they were established in the US and the EU, and one-fourth at the maximum were developed locally for Japan. Regarding drugs that were
doi:10.14982/rsmp.6.255
fatcat:svfvbpkinbbrvgkonhm3dr6xtq