Back to: Introduction to FDA’s Office of Trade and Global Partnerships
🔔 Note: Stop playback at 16:53 to complete this lesson.
Presenter
Eloisa Noriega
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
This presentation introduces the FDA’s Mutual Recognition Agreements (MRAs), which are international agreements allowing two or more countries to recognize each other’s drug inspection processes. Under the Food and Drug Administration Safety and Innovation Act, the FDA can enter these agreements with foreign regulatory authorities deemed capable of conducting inspections that meet U.S. requirements. The primary objectives of MRAs are to enhance regulatory efficiency, avoid duplicative inspections, and enable the reallocation of resources towards higher public health risk facilities globally, a need particularly underscored by the COVID-19 pandemic. The FDA currently has three MRAs in force with the European Union, the United Kingdom, and Switzerland, all of whom the FDA has found capable after comprehensive assessments. A “capable” authority possesses legal and regulatory authority, manages conflicts of interest, evaluates and mitigates risks, maintains oversight, uses adequate resources, employs trained inspectors, and has tools to protect the public. It is important to note that “capable” does not require identical procedures to the FDA’s. Both the FDA and its MRA partners retain the right to inspect facilities at any time, and while enforcement actions may differ due to varied legal systems, their impact is similar. Certain products, such as advanced therapy medicinal products and human blood, are excluded from these MRAs. The FDA’s Office of Trade and Global Partnerships plays a vital role in identifying partners, facilitating negotiations, ensuring information exchange, and overseeing the implementation and maintenance of these agreements.