MRA: FDA accepts four new States

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.

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.