FDA News Release: Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm 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 ...
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