Posted by Michael Wonder on 04 Jun 2018
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
1 June 2018 - Agreement now operational between 14 EU Member States and FDA.
The mutual recognition agreement between the EU and the US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US FDA confirmed the capability of two additional EU Member States (Lithuania and Ireland) to carry out good manufacturing practice inspections at a level equivalent to the US. There are now a total of 14 Member States whose inspection results the FDA can rely on to replace their own inspections.
In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1 November 2017, EU Member States and the EMA can rely on inspection results from the FDA to replace their own inspections. On 1 November 2017, the FDA confirmed the capability of eight EU Member States. Four further EU Member States were recognised by the FDA on 1 March 2018.
