International Programs
Europe
FDA’s presence in Europe greatly facilitates and enhances the large body of work on which FDA currently collaborates with its European counterpart agencies. FDA’s activities with the European Commission (EC) include extensive regulatory cooperation on all products that FDA regulates, i.e., cosmetics, drugs, biological products, food, medical devices, and veterinary medical products. The European Medicines Agency (EMA) is one of FDA’s closest regulatory partners in the area of medical product review. FDA maintains an active robust bilateral relationship with EMA, along with national regulatory authorities throughout Europe. Confidentiality arrangements facilitate information exchange with the EC, EMA, and European Food Safety Authority (EFSA), and at the national level with Austria, Belgium, Denmark, France, Germany, Ireland, Italy, The Netherlands, Sweden, Switzerland, and the United Kingdom. FDA’s activities include working 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.
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U.S. FDA - European Union
- Program to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers, February 2012
Enhancing GMP Inspection Cooperation between EMA and FDA Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011 (PDF - 333KB)Frequently Asked Questions and Answers for the Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011 (PDF - 89KB)Final report on the International API inspection Pilot Programme, May 2011 (PDF - 147KB)- Interactions between the European Medicines Agency and U.S. Food and Drug Administration September 2009-September 2010 (June 2011) (PDF - 278KB)
- Announcement that the FDA and EMA have received first parallel quality-by-design application
EMA-FDA pilot program for parallel assessment of Quality by Design applications (PDF - 103KB)- Press Release: FDA, EMA announce pilot for parallel assessment of Quality by Design applications
FDA - European Medicines Agency - Frequently Asked Questions and Answers EMEA-FDA GCP Initiative
Transatlantic Task Force on Antimicrobial Resistance
International Arrangements
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