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China, U.S. FDA Drug Inspections Said Unaffected By Changes In SFDA

The mutual inspection arrangement between the FDAs of China and the U.S. remain unaffected by recent changes in China's regulatory processes for food and drugs.

The mutual inspection arrangement between the FDAs of China and the U.S. remain unaffected by recent changes in China's regulatory processes for food and drugs. The head of the U.S. FDA's China office said in an interview most of the work with the newly renamed CFDA is "business as usual" with no change in day-to-day operations. Each nation is operating under an agreement that allows each to inspect facilities in the other country for its imported products. Christopher Hickey, director of the U.S. FDA operation in China, said it is yet to be determined if the CFDA changes would have an impact on clinical trials, international standards harmonization or approvals of drugs and medical devices. (Click here for more

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