Joint FDA-EMA Inspection Program to Launch in January 2012

Posted 21 December 2011 | By

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing facility inspection data in their respective territories in January to make better use of resources and reduce drugmakers' inspection burdens.  The new collaboration builds on the pilot inspection program the agencies have been trialling the past few years.  According to the results released in August, the trial program has reduced the number of duplicate inspections and established a master list of active pharmaceutical ingredient supply facilities.  According to a document issued by the FDA and EMA earlier this month, the general approach will be to focus on information exchange for sites already known to each authority that have a history of satisfactory GMP compliance following previous inspections. (in-pharmatechnologist)


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