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

The Office of Trade and Global Partnerships (OTGP) is FDA's lead office for international trade policy, mutual recognition agreements, and formal partnerships with foreign regulatory authorities and international organizations. OTGP sits within FDA's Office of Global Policy and Strategy (OGPS) and works to ensure that FDA's high standards for the safety, quality, and effectiveness of regulated products are reflected in U.S. trade policy and global regulatory frameworks.

Trade and regulatory policy are closely connected. The rules that govern how products cross international borders directly affect the safety of FDA-regulated products that Americans use every day. OTGP ensures that FDA has a seat at the table when those rules are written, and that public health remains protected as global commerce grows.

Trade

Domestic and foreign trade policies have significant implications for FDA-regulated products. When trade agreements are negotiated or tariff policies are set, the standards applied to FDA-regulated products are often at stake. OTGP works to ensure those standards reflect FDA's rigorous, science-based approach, protecting American consumers while also creating a level playing field for U.S. manufacturers, who already meet FDA's requirements.

To lead FDA's trade portfolio, OTGP:

Establishing FDA’s trade objectives in consultation with experts across the Agency, including scientific and technical staff in FDA's product Centers
Works with the U.S. government interagency including the Office of the U.S. Trade Representative (USTR), the Department of Commerce, and other agencies, to help formulate U.S. trade policy
Representing FDA in U.S. delegations to the World Trade Organization (WTO) Technical Barriers to Trade (TBT) and Sanitary and Phytosanitary Measures (SPS) Committees, and in discussions or negotiations with trading partners
Advocates for science- and risk-based standards in trade agreements covering medical products, food, and feed, supporting the safety of imports while ensuring U.S. is not at a competitive disadvantage
Promotes Good Regulatory Practices (GRPs) globally, which are standards that encourage transparent, predictable, evidence-based rulemaking that facilitates safe trade and reduces unnecessary barriers
Engages on tariff policy when import tariffs affect FDA-regulated products or the security of U.S. supply chains for medicines and medical devices

Good Regulatory Practices (GRPs): Internationally recognized principles that promote high-quality, transparent, and consistent regulation. They include public consultation, science-based decision-making, and alignment with international standards, all of which help facilitate trade while protecting public health.

Mutual Recognition Agreements

Mutual recognition agreements (MRAs) create efficiencies for U.S. foreign regulatory systems by allowing trusted regulatory authorities to rely on each other's inspection findings, so that the facility does not need to be inspected separately by every country's government. For pharmaceutical manufacturers, this means fewer duplicative inspections, lower compliance costs, and faster patient access to safe medicines.

FDA currently has MRAs with several trusted partners, including the European Union, the United Kingdom, and Switzerland. Under these agreements, FDA and its counterpart agencies share inspection results and accept each other's finding for certain types of drug manufacturing facilities after verifying that the partner's regulatory system meets FDA's standards.

To lead FDA's MRA portfolio, OTGP:

Evaluates potential new MRA partners by assessing their regulatory frameworks, public health benefit, and alignment with FDA's standards
Conducts capability assessments of MRA partner authorities to verify they meet the requirements needed to participate in the program
Conducts negotiations with potential new partners to establish the terms of mutual recognition
Manages Joint Committee meetings with existing MRA partners to maintain active bilateral dialogue and ensure commitments are met
Monitors MRA implementation and progress to ensure agreements are functioning as intended and delivering public health benefits
Maintains transparent public information about the status of FDA's MRA partnerships

Learn more about Mutual Recognition Agreements

International Arrangements

FDA works to foster international partnerships with counterpart foreign governments and international organizations. These partnerships allow FDA and its counterparts to share information, coordinate on emerging issues, and work together to protect public health across borders.

OTGP formalizes these partnerships through a range of legal instruments, including:

Confidentiality commitments, which allow FDA and a foreign counterpart to share non-public regulatory information such as inspection findings or product safety data, in ways that protect sensitive information while supporting stronger oversight.
Memoranda of Understanding (MOUs), which establish a framework for ongoing cooperation between FDA and a foreign regulatory authority or international organization
Cooperative arrangements, which support joint work on specific regulatory issues, such as harmonizing standards, conducting joint inspections, or building regulatory capacity in partner countries

These arrangements help extend the reach of FDA's oversight, improve the safety of imported products, and build the global regulatory infrastructure that patients and consumers rely on.

Learn more about Mutual Recognition Agreements

Contact

Joseph Rieras, J.D., Director

U.S. Food and Drug Administration

Office of Global Policy and Strategy

Office of Trade and Global Partnerships (OTGP)

10903 New Hampshire Avenue, Building 31/32

Silver Spring, MD 20993-0002

Contact: FDA_Global@fda.hhs.gov

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