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  1. Office of Global Policy and Strategy

Office of Trade, Mutual Recognition, and International Arrangements Also referred to as: OTMRIA

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OTMIRA Ship

The Office of Trade, Mutual Recognition and International Arrangements (OTMRIA) 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. 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;
  • 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.

Focus on OTMRIA

Contact:

FDA_Global@fda.hhs.gov

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