About FDA

Office of Global Regulatory Operations and Policy (GO)

FDA Globalization- Offices in China, Europe, Latin America, and IndiaThe 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


A New World for Pharmaceutical Inspections- The Mutual Recognition Agreement

Please click here for Information on the Mutual Recognition Agreement

GO Facts at a Glance (May 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.

Work:

  • 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

Contact FDA

 
Office of Global Regulatory Operations and Policy

10903 New Hampshire Avenue

Building 1

Silver Spring, MD 20993

Page Last Updated: 07/12/2018
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