MRA Countdown: 10, 6, 4, 2, ...
Recommendation
14/15 October 2026
Vienna, Austria
Quality Oversight of Pharmaceutical Contract Manufacturing Organisations
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The Mutual Recognition Agreement (MRA) with the US is on track. In a press announcement from 11 June the EMA informed that Luxembourg and the Netherlands have joined the agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU Member States.
Now 26 countries are included. Germany and Slovakia are the only EU member states that have not been added yet. By 15 July 2019, however, all authorities and countries should have been approved and acknowledged by FDA.
If the agreement is in force (and only then!), the additional full testing of a drug imported from the USA will no longer be necessary. This also applies to countries that have already been recognised.
Source: EMA press release entitled "Two additional countries to benefit from EU-US mutual recognition agreement for inspections".
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