MRA with FDA: Two new States accepted
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
After a positive assessment, the US Food and Drug Administration (FDA) has approved Lithuania and Ireland to be fully covered by the current EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers. They are now also "recognised as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines".
The total number of countries accepted by the FDA is now 14: Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Hungary, Romania plus Lithuania and Ireland.
Other EU member states will be added as their evaluation is completed by the US. According to an older EMA press release, "Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track."
Related GMP News
26.10.2026Inadequate Supplier Oversight and missing Tests: Lessons from an FDA Warning Letter
21.10.2026FDA Cites Serious CGMP Deficiencies at Stream2Sea
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