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The objective of this study was to analyze the factors contributing to the delay in the launching of neurological drugs in Japan. Methods We analyzed data from Japan and the US for the approval of 36 standard neurological drugs and examined the potential factors that may cause the delay of their launch. Results Of the 36 standard neurological drugs, all of which were approved in the US, only 21 were introduced in Japan from June 1999 to April 2010, whereas the other 15, whose indications were Alzheimer disease, epilepsy, migraine, multiple sclerosis, and Parkinson disease, remained unapproved. The US led Japan in the number of introductions (20 versus 1), with introductions in Japan occurring at a median of 87 months after introductions in the US. Japan\u0027s review time of new drug applications (23 months) could not explain this lag. In 15 of the 21 approved drugs, the application data package included overseas data. 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Delays in Neurological Drug Development in Japan
http://hdl.handle.net/10069/25855
http://hdl.handle.net/10069/258554335af5e-7e44-44fc-9927-733310b067fc
名前 / ファイル | ライセンス | アクション |
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IntMed50_1565.pdf (125.8 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2011-09-26 | |||||
タイトル | ||||||
タイトル | Delays in Neurological Drug Development in Japan | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Clinical trials | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Drug approval | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Food and drug administration | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | International conference on har-monisation of technical requirements for registration of pharmaceuticals for human use (ICH) | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Shimazawa, Rumiko
× Shimazawa, Rumiko× Ikeda, Masayuki |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Objective The lag in the approval and development of neurological drugs between Japan and other countries has been a major issue for patients with neurological diseases. The objective of this study was to analyze the factors contributing to the delay in the launching of neurological drugs in Japan. Methods We analyzed data from Japan and the US for the approval of 36 standard neurological drugs and examined the potential factors that may cause the delay of their launch. Results Of the 36 standard neurological drugs, all of which were approved in the US, only 21 were introduced in Japan from June 1999 to April 2010, whereas the other 15, whose indications were Alzheimer disease, epilepsy, migraine, multiple sclerosis, and Parkinson disease, remained unapproved. The US led Japan in the number of introductions (20 versus 1), with introductions in Japan occurring at a median of 87 months after introductions in the US. Japan's review time of new drug applications (23 months) could not explain this lag. In 15 of the 21 approved drugs, the application data package included overseas data. The mean review time of these 15 drugs was significantly shorter than that of the other 6 drugs without overseas data. The maximum daily doses of 7 of the drugs were higher in the US than in Japan. Conclusion These results show that there is still a large gap between Japan and the US with regard to access to standard neurological drugs, despite several important reforms in the Japanese drug approval system. | |||||
書誌情報 |
Internal Medicine 巻 50, 号 15, p. 1565-1568, 発行日 2011-08-01 |
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出版者 | ||||||
出版者 | The Japanese Society of Internal Medicine | |||||
出版者別言語 | ||||||
日本内科学会 | ||||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 09182918 | |||||
書誌レコードID | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA10827774 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.2169/internalmedicine.50.5061 | |||||
権利 | ||||||
権利情報 | Copyright (c) 2011 by The Japanese Society of Internal Medicine | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Internal Medicine, 50(15), pp.1565-1568; 2011 |