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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: 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.

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