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International Pharmaceutical Regulatory Monitor
October 2012 | Vol. 40 No. 10
Japan: PMDA Notice Shows Increasing Willingness to Accept Global Clinical Trials
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) cited increasing regulatory cooperation with China and South Korea in saying it will now accept new drug applications that rely on well-designed, well-conducted global clinical trials in the neighboring East Asian nations. Includes the full text of Japan’s Basic Principles on Foreign Clinical Trials.
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