[Investigation on new molecular entities of drugs approved in three regions, Japan, U.S. and EU--common and preceding approvals in current 4 years].

Q4 Medicine Bulletin of National Institute of Health Sciences Pub Date : 2006-01-01
Mitsuo Saito, Mutsuko Hirata-Koizumi, Shinji Miyake, Ryuichi Hasegawa
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引用次数: 0

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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【日本、美国、欧盟3个地区获批药物新分子实体调查——当前4年常见及既往获批情况】。
2005年获批的新分子实体(nme)在日本分别为17个、美国20个和欧盟18个。在2002 - 2005年期间,在日本和至少一个其他地区获得批准的53种nme中,到2005年,53种nme在美国获得批准,25种在欧盟获得批准,但只有日本和欧盟之间没有共同的批准。另一方面,在此期间,有26个nme在美国和欧盟获得单独批准。在两个或三个地区获得批准的79个国家中,日本是3个,美国是62个,欧盟是14个。
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