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Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity‐Related Drug Response Factors
Author(s) -
Ichimaru K,
Toyoshima S,
Uyama Y
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.285
Subject(s) - drug development , drug , context (archaeology) , ethnic group , clinical pharmacology , regulatory agency , agency (philosophy) , pharmacology , clinical trial , medicine , drug approval , engineering ethics , political science , public administration , sociology , law , social science , biology , engineering , paleontology
In recent years, drug development has become dramatically globalized, and global clinical trials (GCTs) are being conducted in both International Conference on Harmonisation (ICH) and non‐ICH regions. 1 To ensure the success of global drug development, ethnicity‐related factors must be taken into consideration. In this article, the experiences and initiatives of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are described, and the contours of an effective global drug development strategy are discussed. Clinical Pharmacology & Therapeutics (2010) 87 3, 362–366. doi: 10.1038/clpt.2009.285