FDA Outlines Plan for Requesting Records from Chinese Drugmakers

FDA Commissioner Stephen Hahn offered more details of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak.

While FDA inspections are suspended in China, the agency may ask firms for facility records ahead of or instead of inspections, allowing the agency to review records ahead of time and identify plants that most warrant an inspection.

“These records will help the agency when we resume drug inspections in China,” allowing it to focus early inspections and help prevent an inspection backlog, he said.

The commissioner also addressed ongoing concerns that the coronavirus could be transmitted by products imported from abroad — especially from China — emphasizing that there is no evidence to suggest imported products could spread the virus.