FDANews
The QMN Weekly Bulletin

FDA to Recognize GMP Inspections From Eight EU Countries

Nov. 3, 2017

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities  in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year.

FDA Commissioner Scott Gottlieb described the GMP partnerships, taking effect Nov. 1, as getting the “the greatest bang for our collective inspectional buck.”

“By partnering with these countries we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries,” Gottlieb said. Currently, the FDA is working to assess the capabilities of all 28 EU countries by July 2019.

In June, the European Commission determined that the FDA’s GMP inspections would be equivalent to the EU’s, to avoid duplication of drug inspections. Since then, the EMA has been deferring its work in the United States. In 2016, EU inspectors conducted 129 GMP inspections in the U.S.

The pact to amend the pharmaceutical annex to the 1998 mutual recognition agreement was settled upon in March, following three years of negotiations. The agreement also allows regulators to accept GMP documents from outside their territories.

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