Back to: Introduction to FDA’s Office of Trade and Global Partnerships
Presenter
Azada Hafiz
International Policy Analyst
Office of Trade and Global Partnerships (OTGP)
Office of Global Policy and Strategy (OGPS)
Office of the Commissioner (OC)
US Food and Drug Administration (FDA)
Abstract
The FDA actively engages in international partnerships to address the challenges of complex global pharmaceutical supply chains and ensure the safety, development, and availability of drugs for U.S. consumers. To achieve this, the FDA utilizes two main types of international arrangements: cooperative arrangements, which are non-binding understandings for collaboration, and confidentiality commitments, which are essential for sharing nonpublic regulatory information while adhering to disclosure laws. These commitments form the foundation for critical information exchange with global counterparts across the Americas, Europe, Africa, Asia, and Australia, as well as with international organizations like the World Health Organization. This exchange enhances FDA’s oversight, deepens understanding of supply chain complexities, improves the ability to detect and remove violative products, and provides better regulatory guidance. Specific outcomes include participation in structured scientific and policy discussions (clusters), collaborative review processes like Project Orbis for oncology drugs, and Mutual Recognition Agreements (MRAs) with the European Union, the United Kingdom, and Switzerland. MRAs allow the exchange of inspection-related information, leading to greater efficiencies by reallocating inspection resources to higher-risk manufacturing facilities globally and strengthening the international regulatory community’s ability to respond to supply chain disruptions and shortages. The Office of Trade and Global Partnerships oversees the development and implementation of these crucial international arrangements.