FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

October 31, 2017 — The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United ...
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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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