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  • Title: [Investigation on new molecular entities of drugs approved in three regions, Japan, U.S. and EU--common and preceding approvals in current 4 years].
    Author: Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R.
    Journal: Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2006; (124):80-2. PubMed ID: 17405529.
    Abstract:
    The number of new molecular entities (NMEs) approved in 2005 was 17 in Japan, 20 in US and 18 in EU, respectively. Among 53 NMEs approved in Japan and at least one other region during 2002 to 2005, 53 NMEs had been approved in US and 25 in EU by 2005, but there were no common approvals only between Japan and EU. On the other hand, 26 NMEs were solely approved in US and EU during this period. Among 79 NMEs approved in either two or three regions, the number of preceding NMEs was 3 in Japan, 62 in U.S. and 14 in EU.
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