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.
FDA - EMA Announcement
The U.S. FDA and EMA today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals.
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)