FDA Agrees to Accept Inspections for All 28 EU Member States

The FDA has agreed to recognize inspections by all 28 EU member states under the U.S.-EU's mutual recognition agreement (MRA) for GMP inspections, following five years of work.

The MRA, which allows the U.S. and EU use on each other’s GMP inspections and avoid conducting duplicate inspections, is considered to be fully implemented now that all member states’ inspection capabilities have been verified as on par with those of the FDA.

“We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results,” said Guido Rasi, executive director of the European Medicines Agency.