US FDA Puts All China Drug Inspections On Hold Due To Coronavirus Outbreak
February and March inspections deferred unless any are deemed mission critical. China director remains behind as staff evacuate.
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Indian pharmaceutical companies will soon be asked to seek a no objection certificate for the export of 12 APIs and their formulations, as the country deals with Chinese raw material supply disruptions on the back of the coronavirus crisis. However, the move is not expected to impact the export quantum for now.
The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.
US FDA’s drug shortage team continues to check in with sponsors, but so far the infections and quarantines have not impacted drug production.