FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

US/EU Mutual Recognition Agreement

• Text of Complete Agreement

• SUMMARY of the FDA-Related Elements

• Mutual Recognition of Pharmaceutical Good Manufacturing Practice Inspection Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports -- Final Rule: (315K text file)

• Memorandum of Understanding Between the Food and Drug Administration and the Office of the United States Trade Representative

• The Pharmaceutical Good Manufacturing Practice Annex

• The Medical Device Annex

International Programs Home Page
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Office of International Programs