Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

March 2, 2017 – The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Drug … (leggi tutto)