New countries to benefit from EU-US mutual recognition for inspections

Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration, effective June 10.

The FDA thus confirmed the capability of these two additional EU member states to carry out Good Manufacturing Practice (GMP) inspections at a level equivalent to the USA. The agreement mutually recognizes inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 26 member states whose inspection results can 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 November 1, 2017, EU member states and the European Medicines Agency can rely on inspection results from the FDA.