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  1. Office of Global Policy and Strategy

Office of Trade and Global Partnerships Also referred to as: OTGP


The Office of Trade and Global Partnerships (OTGP) serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts. OTGP also serves as the FDA lead for addressing cross-cutting issues in multilateral organizations such as the World Health Organization, and coordinates issues arising in multilateral forums within FDA. The office performs the following duties:

  • Establishing FDA’s trade objectives and in consultation with subject matter experts in the Office of the Commissioner and product centers;
  • Working with other federal agencies to help formulate U.S. trade policy;
  • Representing FDA at the World Trade Organization, and in discussions or negotiations with trading partners;
  • Representing FDA and supporting FDA leadership at the World Health Organization, the United Nations, and other multilateral organizations; 
  • Working with other federal agencies in the development of U.S. positions in multilateral organizations;
  • Negotiating mutual recognition agreements on behalf of the agency;
  • Working with FDA’s product centers to establish cooperative arrangements (e.g., Memorandum of Understanding; Statement of Cooperation) with foreign government agencies and international organizations in support of mutual regulatory cooperation;
  • Establishing confidentiality commitments to allow FDA’s product centers to share and receive certain non-public information for cooperative law enforcement or regulatory activity purposes;
  • Developing FDA-wide policies and procedures for sharing of non-public information in reliance of confidentiality commitments; and
  • Providing implementation guidance on international arrangements;
  • Establishing, managing, and funding cooperative agreements with international partners in support of FDA priorities.

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