MRA: FDA accepts four new States

Recommendation
12/13 November 2025
How to implement EU-GMP Chapter 8
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.
Related GMP News
22.10.2025EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated
22.10.2025FDA continues to take Root Cause Analysis and CAPA very seriously
14.10.2025Two new GDP Non-Compliance Reports from Romania
01.10.2025Alternative Inspection Methods of the FDA
24.09.2025FDA issues final Guidance on Remote Oversight Tools
24.09.2025Four Warning Letter concerning CAPA and Root Cause Analysis published


