Posted by Michael Wonder on 20 Sep 2018
Portugal to also benefit from EU-US mutual recognition agreement for inspections
20 September 2018 - Agreement now operational between 15 EU Member States and FDA.
The mutual recognition agreement between the European Union and the United States to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US FDA confirmed on 14 September 2018 the capability of one additional EU Member State (Portugal) to carry out good manufacturing practice inspections at a level equivalent to the US.
There are now a total of 15 Member States whose inspection results the FDA can rely on to replace their own inspections.
