Posted by Michael Wonder on 01 Mar 2018
Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
1 March 2018 - Agreement now operational between 12 EU Member States and FDA
The mutual recognition agreement between the European Union 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 FDA confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice 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.
Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.
