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News From the Food and Drug Administration
April 18, 2017

US-EU Drug Inspection Agreement

JAMA. 2017;317(15):1518. doi:10.1001/jama.2017.3632

A recent agreement established closer ties between the FDA and the European Union (EU) to ensure the safety of drugs imported into the United States from pharmaceutical manufacturers in EU countries and other parts of the world.

Formalized last month, the arrangement dates back to 1998 when, as part of a US-EU trade agreement, both sides agreed to accept each other’s inspection results to confirm that drug makers follow good manufacturing processes. However, that part of the trade agreement was never fully implemented. In 2012, Congress gave the FDA authority to recognize foreign agencies’ inspections if it determined that regulatory agencies in those countries met US inspection standards. Since 2014, the FDA and the EU have collaborated to examine each other’s inspection processes and discuss the pros and cons of an agreement.

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