Offer extended until 31 July 2026: get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
MRA: FDA accepts four new States
Recommendation
1/2 December 2026
How to implement EU-GMP Chapter 8
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 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
28.10.2026Inadequate 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