EU accepts results from FDA GMP inspections for sites outside the US

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EU accepts results from FDA GMP inspections for sites outside the US

INICIO/Políticas y legislación | Posted 27/01/2026 0 Post your comment

On 1 October 2025, the European Medicines Agency (EMA) announced a significant enhancement to the existing Mutual Recognition Agreement (MRA) with the US Food and Drug Administration (FDA). As a result, EU regulators will be able to voluntarily rely on FDA inspections of manufacturing sites outside the US when assessing human-medicinal-product applications and relevant variations [1].

Since 1 November 2017, the EU–US MRA on Good Manufacturing Practice (GMP) inspections has been in effect. Under this agreement, the EU and US mutually recognise each other’s GMP inspections, however,EU authorities have largely relied on FDA inspections of sites located within the US or on inspections conducted by EU Member State inspectorates.

Following a successful Pilot program announced in 2023, EU authorities may now also voluntarily rely on FDA inspections conducted outside the US. These are based on case-by-case risk assessments and proactive sharing of inspection reports by applicants. By recognising FDA inspection outcomes from third countries, EU regulators can reduce duplication of inspection activity and focus their inspection efforts on higher-risk or previously less-inspected sites. The ability to rely on such inspection results supports more efficient global regulatory oversight and aligns with broader efforts to manage risk across pharmaceutical supply chains.

In May 2023, the MRA was extended to veterinary products, after the EU confirmed the FDA’s equivalence for veterinary GMP inspections. In the future, the scope of the agreement may extend to vaccines, plasma-derived, and investigational products after further evaluations.

Overall, this development enables the EU to recognise even broader FDA inspection outcomes, thereby advancing efficiency, trust-based oversight and global supply-chain resilience, while retaining the rigour and sovereignty of regulatory decision-making.

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Reference
1. questions-and-answers-impact-mutual-recognition-agreement-between-european-union-and-united-states-7-August-2024_en (1)

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