The headquarters of the FDA’s Europe Office is a part of the U.S. Mission to the European Union (USEU) located in Brussels, Belgium. Europe Office staffs are also located at the European Medicines Agency (EMA) in London, United Kingdom and at FDA headquarters in Silver Spring, MD.
The mission of the FDA Europe Office is to have a deep and sophisticated understanding of the European Union (EU) institutions and Member States that interact with and have an impact on products regulated by the FDA. A multi-disciplinary team analyzes key policy issues for the FDA and identifies creative solutions for advancing FDA’s international objectives that contribute to measurable improvements in global public health. The Europe Office also partners with EU Institutions, Member States, industry and others to find better ways to share sensitive scientific data. This information is critical to better inform risk analysis globally. The Europe Office endeavors to advance all efforts that will lead to mutual reliance on and recognition of EU regulatory systems. The ultimate goal is to protect consumers, while at the same time facilitating access to the benefits of innovative products and technology.
European institutions comprise some of the most robust and sophisticated analytical, laboratory, and risk assessment bodies outside the U.S. and are major contributors globally with significant aid, training and outreach to developing countries. The European Medicines Agency (EMA) located in London, U.K. and the European Food Safety Authority (EFSA) located in Parma, Italy are two key agencies that perform critical roles in coordinating the expert assessments of the national competent authorities and conducting independent risk assessment that ultimately allow decisions on marketed products and risk management measures to be taken at the EU-level by the European Commission. The European Directorate for the Quality of Medicines and Healthcare located in Strasbourg is a leading organization under the Council of Europe that protects public health by developing, implementing, and monitoring the application of quality standards for medicines and their safe use; its standards are recognized as a scientific benchmark worldwide.
Beyond its own institutions, Europe hosts the headquarters of many international multilateral organizations including the World Health Organization, the United Nations Food and Agriculture Organization, the World Organization for Animal Health, the Codex Alimentarius Commission, the Organization for Economic Development, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme and others.
Regulatory dialogue between the U.S. and Europe is significant. Known also as the “Transatlantic” dialogue, bilateral initiatives such as the Transatlantic Economic Council, Transatlantic Business Dialogue, Transatlantic Consumer Dialogue, and Transatlantic Task Force on Antimicrobial Resistance demonstrate cooperation and collaboration unique to the U.S. and Europe. FDA’s Europe Office works closely with other U.S. government agencies in Europe, as well as with industry, multilateral organizations, and consumer groups on the public health issues of importance to FDA.