MRA: FDA accepts four new States
Recommendation

14/15 October 2026
Vienna, Austria
Quality Oversight of Pharmaceutical Contract Manufacturing Organisations
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
23.09.2026FDA Inspection as GMP Evidence? Swissmedic Opens Up a New Option
23.09.2026New: Coordination of GMP Inspections for Centrally Authorised Products
16.09.2026How GMP Non-Compliance can stop a Marketing Authorisation Application
10.09.2026FDA Warning Letter: Inadequate Warehouse Controls and Lot Traceability
09.09.2026Specified Microorganisms and More - FDA Warning Letter


