Luxembourg and The Netherlands benefit from the EU-US Mutual Recognition Agreement for Inspections

Luxembourg and the Netherlands have now been incorporated into the Mutual Recognition Agreement (MRA) between the European Union (EU) and the U.S. Food and Drug Administration (FDA). Through this agreement, the FDA confirms that both Member States have the capability to conduct Good Manufacturing Practice (GMP) inspections at a level equivalent to that of the United States.

The MRA allows the FDA to rely on GMP inspections carried out by recognized EU authorities, thereby reducing the need for duplicate inspections of human medicine manufacturing sites across the two regions. With the inclusion of these countries, the FDA now recognizes inspections performed by 26 EU Member States.

Benefits of the Mutual Recognition Agreement for EU Authorities and the FDA

• Enables both regulators to concentrate inspection resources on regions outside the EU and the U.S., where many active pharmaceutical ingredients and finished medicines are produced. 
• Reduces administrative workload and the financial burden of redundant inspections for pharmaceutical manufacturers, including smaller companies. 
• Provides reassurance to patients that medicines meet high standards for quality, safety, and efficacy, regardless of their manufacturing location. 
• Enhances the ability of authorities to detect and address potential issues at manufacturing facilities before they escalate into public health risks. 
• Allows regulators to prioritize inspections for higher-risk products and facilities.

The expansion of the MRA strengthens regulatory cooperation, increases efficiency, and supports a more reliable global pharmaceutical supply chain.