Four More EU Member States in US/EU MRA

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FDA confirmed the capability of four more EU Member States ─ Czech Republic, Greece, Hungary, and Romania ─ to carry out GMP inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA may rely on to replace their own inspections. FDA expects to complete its capability assessment of all EU inspectorates by July 2019.

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