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13.02.2019

EU-FDA MRA: Soon all States on board

Recommendation

2/3 September 2026
Copenhagen, Denmark

Root Cause Analysis
When “Human Error” isn’t enough: Successful Failure Investigation

The Mutual Recognition Agreement (MRA) with the USA was supplemented by two further countries: Poland and Slovenia. Now 22 countries are already recognised. Among other countries, Germany is still missing . On a dedicated webpage of the EMA there is an excellent overview. By 15 July 2019, however, all authorities and countries should have been inspected and approved.

If the agreement is fully 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.

No more inspections?

In exceptional cases, the FDA will continue to travel to the EU for inspections, among other things within the framework of approval procedures (so-called pre-approval inspections). This also became clear at an ECA conference in November 2018, where participants from Spain, Austria and Denmark reported on announced inspections for the year 2019.