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: Cooperative Arrangements (which include Memoranda of Understanding and similar documents) and Confidentiality Commitments.
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.
A Cooperative Arrangement 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.
For additional information about International Arrangements, contact OC-OGPS-IA@fda.hhs.gov.
Domestic, Academia, and Other MOUs
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
- United States Department of Agriculture
- Department of Commerces Foreign Commercial Service
- U.S. Department of State
- U.S. Customs and Border Protection
Recalls & Alerts
- Recalls, Market Withdrawals, and Safety Alerts
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Warning Letters
- FDA Recall Information on Twitter