Considerations when deciding how to develop agile and flexible clinical trial capabilities in Japan

Japan, with a population of 127 million people, is the world’s third-largest economy making it an important development center for new medicines. Japan also ranks third behind only the United States and Switzerland as a consumer of ethical drugs per capita.

In Japan, a drug approval filing strategy utilized global clinical trials that excluded Japan. These trials were followed by smaller bridging studies in Japan, ensuring compliance with ICH E5 guidelines. However, this strategy results in a significant time lag between the initial approval of the new drug outside of Japan and the subsequent approval of the drug inside Japan.

Clinical Trials in Japan: An Enterprise Growth and Management Strategy

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