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FDAnews Drug Daily Bulletin

CFDA Conducted Fewer Foreign Inspections in 2016

June 13, 2017

China’s Food and Drug Administration only carried out a fraction of the dozens of planned GMP inspections of foreign sites last year.

The agency slated 49 overseas facilities for inspection in 2016 but only inspected seven. CFDA planned 34 foreign inspections in 2015 and actually conducted 25. Three companies refused to consent to an inspection, while six other inspections were delayed, the agency reported.

The agency postponed 21 of its planned 2016 inspections to the first quarter of 2017 and delayed another 12 until later in the year because the companies could not “accept inspection” earlier.

“CFDA has been dealing with a lot of domestic drug scandals, and they may lack the bandwidth to conduct overseas GMP inspections at this time,” suggests China regulatory specialist Grace Fu Palma, founder and CEO of China Med Device.

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