International Arrangements

FDA fosters international partnerships with counterpart foreign government agencies and international organizations. The tools that FDA uses to set up and memorialize these partnerships include two categories of International Arrangements: Confidentiality Commitments and Cooperative Arrangements, which include Memoranda of Understanding (MOU) and similar documents.

Confidentiality Commitment

A Confidentiality Commitment (CC) is a document that sets up the legal framework for FDA to share certain kinds of non-public information with FDA counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities. A CC must be in place in order for FDA to share non-public information with a counterpart, but a CC never requires FDA (or its counterpart) to share information. 

• Search Confidentiality Commitments.

Cooperative Arrangement

A Cooperative Arrangement (CA) is a written understanding that FDA can establish with one or more foreign governments or international partners that describes the willingness and good-faith intentions of FDA and its counterpart(s) to engage in cooperative activities. Even with a Cooperative Arrangement in place, the FDA cannot share non-public information unless a Confidentiality Commitment exists. 

• Search Cooperative Arrangements.

Memoranda of Understanding

A Memoranda of Understanding (MOU) is not only used in an international setting. The FDA also has MOUs in other U.S. governmental entities, with academia, and the nonprofit sector. Follow these links for listings:

• Domestic MOUs
• Academic MOUs
• Non-Profit MOUs

Mutual Recognition Agreement

A Mutual Recognition Agreement between the FDA and foreign regulatory authorities allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. The FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements.

For additional information about International Arrangements, contact OC-OGPS-IA@fda.hhs.gov.

Resources For You

• U.S. Department of Health and Human Services
• Centers for Disease Control and Prevention
• National Institutes of Health
• Office of the United States Trade Representative
• U.S. Department of Agriculture
• Department of Commerce Foreign Commercial Service
• U.S. Department of State
• U.S. Customs and Border Protection

Popular Topics

• Mutual Recognition Agreement (MRA)
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