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Recent Trends and Success Factors in Reducing the Lag Time to Approval of New Drugs in Japan
Author(s) -
Honig P K
Publication year - 2014
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.2013.256
Subject(s) - lag , lag time , drug approval , time lag , medicine , pharmacology , intensive care medicine , computer science , drug , biology , computer network , biological system
For many years, approvals of new drugs in Japan have lagged behind those in the United States and Europe. As a result of simultaneous global development strategies, more widespread inclusion of Japan in multiregional clinical trials, and significant reforms and investment in Japan's Pharmaceuticals and Medical Devices Agency reviewer capacity and capability, the drug lag appears to be diminishing. This is allowing new medicines to be approved sooner in Japan, improving the efficiency of drug development and benefiting patients. Clinical Pharmacology & Therapeutics (2014); 95 5, 467–469. doi: 10.1038/clpt.2013.256