FDA/EC/EMEA joint inspections

Executive Summary

FDA has agreed to collaborate with the European Commission and European Medicines Agency on pilot projects involving joint inspections of pharmaceutical manufacturers in the U.S. and EU and of manufacturers of active pharmaceutical ingredients in "third" countries, the Transatlantic Economic Council announced at a May 13 meeting in Brussels. The organizations will also pilot the exchange of inspection results to better identify API manufacturers in third countries and will accelerate efforts to determine "to what extent dedicated production facilities are necessary for certain pharmaceuticals," according to a TEC summary. Formed in 2007, the TEC is designed to foster closer economic standards by harmonizing standards and is comprised of U.S. Cabinet members and European commissioners