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PMDA's Challenge to Accelerate Clinical Development and Review of New Drugs in Japan
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.2010.190
Subject(s) - clinical pharmacology , drug development , agency (philosophy) , medicine , pharmacology , drug , process (computing) , engineering ethics , intensive care medicine , engineering , computer science , sociology , social science , operating system
In recent years, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has conducted several projects to shorten drug development and review times in Japan to resolve the “drug lag.” Key to achieving this goal is greater involvement by the PMDA in drug development through enhancement of scientific consultation and improvement of the review process by reinforcing the operational system, including hiring more reviewers. We discuss here the current projects of the PMDA as well as future challenges. Clinical Pharmacology & Therapeutics (2010) 88 4, 454–457. doi: 10.1038/clpt.2010.190