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FDA to Accept Drug Facility Inspections by Eight European Countries

Wednesday, November 01, 2017
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration announced Oct. 31 that it will recognize drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom as capable of conducting inspections of manufacturing facilities that meet FDA requirements. FDA Commissioner Scott Gottlieb said that by partnering with these countries the FDA can “create greater efficiencies [by] relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries.”

An FDA press release states that some drugs approved in the U.S. are either fully manufactured overseas or made in the U.S. but contain some foreign ingredients. One way the FDA oversees drug manufacturing is by routinely inspecting domestic and foreign drug manufacturing plants for compliance with manufacturing standards that assure quality and product label requirements. Beginning Nov. 1 the FDA will rely on inspectional data obtained by regulatory agencies in the countries listed above.

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