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# U.S., EU Drug Inspection Agreement
- URL: https://www.fdaweb.com/u-s-eu-drug-inspection-agreement/
- Published: 2017-03-02T12:00:00.000Z
- Updated: 2026-09-14T22:09:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138108

FDA and the European Union have finalized a mutual recognition agreement allowing each party to rely on good manufacturing practice inspections of drug manufacturing facilities conducted by the other party within its own borders. The agreement comes at the end of three years of cooperative efforts between FDA and EU drug regulators. An FDA [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm?ref=fdaweb.com) says that FDA and EU drug inspectors will be able to rely on information from drug inspections conducted within each other’s borders. “Ultimately, this will enable FDA and the EU to avoid duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk,” it concludes.

The 2012 FDA Safety and Innovation Act gave the agency authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if FDA determined the authorities are capable of conducting inspections that meet U.S. requirements. FDA says it has observed 14 audits of drug inspectorates across the EU, with more audit observations planned for 2017.