• Clin. Pharmacol. Ther. · Nov 2015

    Review

    Closing the drug lag for new drug submission and review in Japan: An industry perspective.

    • A F Poirier.
    • Pfizer U.S. Regulatory Policy and Global Intelligence, Groton, Connecticut, USA.
    • Clin. Pharmacol. Ther. 2015 Nov 1; 98 (5): 486-8.

    AbstractPrevious publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs. © 2015 American Society for Clinical Pharmacology and Therapeutics.

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