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

Luxembourg and the Netherlands were added into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). FDA confirms the ability of these two European Member States in conducting good manufacturing practice (GMP) inspections equivalent to the United States (US). This agreement recognizes inspections of manufacturing sites for human medicines conducted in different territories. Now FDA relies on a total of 26 Member States whose inspection results can replace their own inspections.

The Mutual benefits for EU authorities and the FDA include:

• The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
• Reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.
• Reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
• Improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk;
• Prioritizing inspections of medicines manufacturing sites for higher risk cases.