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At the May 13 th Transatlantic Economic Council (TEC) (link) the work of the U.S. Food and Drug Administration, the European Commission, and the European Medicines Agency on medicines regulation was noted as an example of close and productive collaboration to the benefit of citizens.
The TEC noted especially the further strengthening of transatlantic cooperation on medicines regulation. Highlighting this further strengthening of regulatory cooperation was the announcement that a first set of projects on medicinal products have been agreed following the administrative simplification workshop held in Brussels in November 2007 (link).
More specifically the following specific priority projects have been agreed:
These results will provide important benefits for industry and patients. It is of particular note that the collaboration on inspections should result in more effective use of resources and a higher safety level of products from third countries.
Work is continuing to identify other items of intensified regulatory collaboration for mutual benefit and this will include further action points from the administrative simplification workshop held in Brussels in November 2007 .
Finally, the FDA and the EMEA have agreed recently on an implementation work plan for veterinary medicinal products regulation and have agreed on a process for offering parallel scientific advice to veterinary medicinal products manufacturers that wish to receive such advice simultaneously from the FDA and EMEA.