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FDA approves eight European regulators to inspect drug factories for U.S.
October 31, 2017 / 4:51 PM / 21 days ago

FDA approves eight European regulators to inspect drug factories for U.S.

NEW YORK (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will allow regulators in eight European countries to determine whether drug manufacturing facilities there meet FDA requirements, freeing up American inspectors to spend more time in higher-risk countries like India and China.

FILE PHOTO: U.S. Food and Drug Commissioner Scott Gottlieb attends an interview at Reuters headquarters in New York City, U.S., October 10, 2017. REUTERS/Eduardo Munoz

The FDA said it will begin relying on inspection data from the regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as of Nov. 1.

A spokeswoman for the agency said in some situations the United States could still do inspections in those countries.

The move is the first step by the FDA to implement an agreement the United States and the EU finalized in March. The European Commission already determined in June that the FDA could carry out inspections for it in the United States.

The FDA said it plans to complete capability assessments for all 28 EU countries by July 2019.

FDA Commissioner Scott Gottlieb said in a statement that partnering with European regulators would allow the agencies to get “the greatest bang for our collective inspectional buck.”

Reporting by Michael Erman; Editing by Dan Grebler

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