Conducting Clinical Trials in China Requires Compliance at Home and Abroad


China has been home to more than 1,800 clinical trials of pharmaceuticals intended for U.S. use. With its large and growing English-speaking population, the country, along with India, is a foreign clinical trial destination poised to “eclipse all the others,” according to recent coverage in Vanity Fair.[1] The country is at the forefront of a larger trend in moving clinical trials abroad—in 2008, 80 percent of new drug applications to the U.S. Food and Drug Administration (FDA) contained data from foreign clinical trials.

China’s State Food and Drug Administration oversees the conduct of clinical trials there, but U.S. companies intending to use foreign data to submit new drug applications here are also governed by U.S. regulations on Good Clinical Practice (GCP).

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