Issue Date: November 6, 2017
U.S., European Union drug inspectors team up
Eight regulatory agencies in the European Union are capable of meeting U.S. FDA requirements for inspecting drug manufacturing facilities, FDA announced on Oct. 31. Earlier this year, U.S. and EU regulators amended a mutual recognition agreement, enabling them to use each other’s inspections of pharmaceutical manufacturing facilities. The intent is to avoid duplicating drug facility inspections and allow regulators to devote more resources to high-risk facilities in other countries. The agencies now recognized by FDA are in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the U.K. FDA is still evaluating the capabilities of agencies in other EU countries to inspect pharmaceutical manufacturing facilities, with the goal of completing all 28 assessments by July 2019. “At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck,” FDA Commissioner Scott Gottlieb says.
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