BRIEF—Poland and Slovenia join EU-US mutual recognition agreement for inspections

The US Food and Drug Administration has confirmed the capability of two additional European Union member states to carry out  good manufacturing practice (GMP) inspections at a level equivalent to the USA.

Poland and Slovenia were included into the mutual recognition agreement between the EU and the USA on February 7, 2019.

The agreement mutually recognises 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 22 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, EU member states and the  EMA can rely on inspection results from the FDA.

Plans for the agreement to be operational in all EU member states by July 15, 2019 are on track, says the EMA.