FDA remains active in Europe - further Inspections despite MRAs

Recently, additional cases have become known in which the U.S. Food and Drug Administration (FDA) has conducted inspections in Europe, in some instances even unannounced. This confirms a trend that has been evident for some time: despite existing Mutual Recognition Agreements (MRAs), the FDA remains active in Europe, sometimes even carrying out unannounced inspections.

Background: What do MRAs actually cover?

Mutual Recognition Agreements between the FDA and European authorities (EU, Switzerland, UK) generally allow for the mutual recognition of GMP inspections. The objective is to avoid duplicate inspections and to use resources more efficiently.

However, the scope of these agreements is limited. They primarily apply to routine inspections, and not all products are covered by MRAs. In addition, so-called "for-cause" inspections remain possible, also unannounced.

Why does the FDA continue to inspect in Europe?

Differences in regulatory expectations still exist, particularly for complex products or new technologies. Moreover, in cases involving critical issues or marketing authorisation procedures, the FDA continues to conduct its own inspections. In practice, not all types of inspections are mutually recognised; for example, "for-cause" inspections are currently not, or only rarely, covered (see FDA Law Blog).

Conclusion for industry

For companies in the EU and Switzerland, this means:

• FDA inspections remain a realistic scenario including at short notice and without prior announcement
• Certified compliance with national or EU GMP requirements alone is not a guarantee to avoid an FDA inspection
• Inspection management should always be "FDA-ready," regardless of MRA status

The current developments build on previously published articles:

• FDA: more unannounced Inspections also outside the US
• Why does the FDA inspect in EU despite the MRA?