FDA approves Hungarian Authority’s inspections from 01. March, 2018

Agreement now operational between 12 EU Member States and FDA

"The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. Today, the US Food and Drug AdministrationExternal link icon (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections."