The Office of Global Regulatory Operations and Policy (also known as GO) comprises the Office of Regulatory Affairs and the Office of International Programs. The Deputy Commissioner for GO provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global collaboration, global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. A fuller explanation of FDA Globalization initiatives can be found on the International Programs - Globalization page
The 2012 Food and Drug Administration Safety and Innovation Act gave FDA the authority to recognize inspections conducted by foreign regulatory authorities, once FDA has determined that a country is capable of conducting inspections that meet U.S. requirements. To implement this new authority, the U.S. and European Union (EU) regulatory authorities launched a strategic collaboration in 2014 to evaluate each other’s regulatory and procedural frameworks for the inspection of drug manufacturers. This successful collaboration led to the amendment of the Pharmaceutical Annex to the 1998 Agreement on Mutual Recognition between the European Community and the United States, in which the U.S. and the EU agreed to recognize each other’s drug inspections.
This Amended Sectoral Annex to the Mutual Recognition Agreement will allow FDA to devote our inspectional resources to other parts of the world where there may be greater risk. Allocating resources to non-U.S. and non-EU inspected manufacturing sites will benefit patients and reduce adverse public health outcomes.
- Mutual Recognition Agreement
- Frequently Asked Questions - The Mutual Recognition Agreement
- Press Release- Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
A key aspect of globalization is the ever-increasing volume and complexity of imports coming to America’s shores. As the chart above documents, last fiscal year, FDA oversaw more than 36.9 million shipments of FDA-regulated products, up from just 15 million shipments a decade ago. These products come from more than 150 nations, are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.
GO Facts at a Glance (January 2017)
Total employees: 5,065
- ORA: 4,899 employees
- OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, and the United Kingdom.
- ORA conducted more than 16,100 domestic inspections in FY 2016. That amounts to roughly 1,340 inspections a month -- or about 44 inspections every day of the week.
- Our labs analyzed approximately 35, 220 samples in FY 2016 – or more than 78 samples analyzed every single day of the week.
- OCI, in Fiscal Year 2016, made 257 arrests, won 274 convictions, and secured nearly $375 million in fines, restitutions, asset seizures and forfeitures.
- Overseas, our personnel conducted 3, 512 inspections in FY 2016, in locations ranging from China to Mexico to India.
- GO has helped achieve the signing of more than 148 International Arrangements with more than 43 nations and multilateral partners regarding FDA's product quality and safety efforts.
Presentations and Testimony
- Remarks to the Food and Drug Law Institute's 2016 Annual Conference
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, May 6, 2016
Remarks to the Food and Drug Law Institute's Global Business Conference
Dara Corrigan, J.D. Associate Commissioner for Global Regulatory Policy, March 16, 2016
FDA Voice Blogs
The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond
Dara Corrigan, J.D., December 7, 2016
Trade Alert: FDA Issues New Import Data Requirements
Howard Sklamberg, J.D. November 30, 2016
SCORE at Six Months: Meeting the Challenge of Complex Recalls
Stephen Ostroff, M.D., and Howard Sklamberg, J.D. October 25, 2016
- First Major FSMA Compliance Dates: Landmarks and Learning Experiences
Stephen Ostroff, M.D., and Howard Sklamberg, J.D. September 19, 2016
- Addressing Global Challenges through Transatlantic Cooperation
Howard Sklamberg, J.D., Lou Valdez, and Donald Prater, July 19, 2016