According to this analysis published in Outsourcing-Pharma.com, the EMA inspects fewer than 1% of clinical trial sites included in marketing authorization application (MAA) submissions that it is meant to regulate. Of course, this is resource related as claimed by almost every other regulatory agency in the world, including the FDA. See here for post where GAO criticized FDA in November for poor implementation of foreign clinical trial inspections.
The Outsourcing Pharma post created an interactive map showing GCP inspections of a country’s trial sites as a percentage of its sites included in MAA submissions. The map can be filtered to show the percentage of inspections in any year from 2005 to 2009. Furthermore, clicking on a region in the graph below filters the map to show data from countries in that part of the world.
Posted by Bruce Lehr December 13th 2010.
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