Posted by Michael Wonder on 29 Nov 2018
Five additional countries to benefit from EU-US mutual recognition agreement for inspections
29 November 2018 - In November 2018, the US FDA confirmed the capability of five additional EU Member States to carry out good manufacturing practice inspections at a level equivalent to the United States (US).
Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the EU and the US on 16 November and Estonia on 28 November 2018. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and as of today, the FDA will rely on a total of 20 Member States whose inspection results can replace their own inspections.
