U.S. FDA Sees Progress Working Within China, And More Help Is On The Way

FDA hopes an expanded staff in China will help overcome new hurdles as the agency learns more about the country's manufacturing and quality system processes.

BEIJING – Nearly four years into U.S. FDA's plan to use in-country offices to inspect and analyze Chinese products before they reach U.S. shores, the agency has seen closer collaboration and institutionalized involvement with its Chinese counterparts and a broadened geographic coverage in the country. However, a number of challenges remain, according to FDA's China Country Director Christopher Hickey.

The challenges range from the sheer number of the Chinese producers to the multiple roles Chinese regulators have to play....

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