FDA Recognizes Drug Facility Inspections by Eight EU Countries
The Food and Drug Administration will recognize inspections of pharmaceutical manufacturing facilities by eight countries in the European Union, it said. The agency has determined that regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom are “capable of conducting inspections of manufacturing facilities that meet FDA requirements,” it said. FDA will begin relying on data from inspections by those countries to determine the compliance of pharmaceutical and pharmaceutical ingredient manufacturers beginning Nov. 1, it said.
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The decision to recognize the eight countries comes as part of implementation of a mutual recognition agreement signed in 1998 that “enables U.S. and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities,” FDA said. The European Commission recognized FDA’s ability to conduct current good manufacturing practice inspections in June 2017, it said. Completion of these assessments “enables the FDA and the EU to avoid duplication of drug inspections and allows regulators to devote more resources to other manufacturing facilities in countries where there may be greater risk,” FDA said.
“Beginning November 1 we will take the unprecedented and significant step forward in realizing the key benefits of the Mutual Recognition Agreement with our European counterparts in that we will now rely on the inspectional data obtained by these eight regulatory agencies,” said Dara Corrigan, FDA acting deputy commissioner-global regulatory operations and policy. “The progress made so far puts us on track to meet our goal of completing all 28 capability assessments in the EU by July 2019,” she said.