MRA: FDA accepts four new States

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

After a positive assessment, the US Food and Drug Administration (FDA) has approved four additional EU Member States to be fully covered by the current EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers.

In November 2018, the FDA confirmed the capability of Belgium, Denmark, Finland and Latvia. This means that the FDA can now rely on a total of 19 Member States to replace their own inspections - in addition to those mentioned these are:Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Austria, Hungary, Romania, Lithuania, Ireland and Portugal.