FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

U.S.-EU Partnership on GMP Inspections Adds Five Countries

Dec. 7, 2018

The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union.

Recognition of the five additional EU member states means that 20 of the EU’s 28 member states can be relied upon to conduct inspections equivalent to those of the FDA. The European Medicines Agency (EMA) says plans are “on track” for the agreement to be operational in all EU member states by July 15, 2019.

The mutual recognition agreement, which was overhauled in March 2017, aims to cut the cost of duplicate inspections so agencies can shift resources to facilities in China, India and other countries that manufacture drugs and APIs for sale in the U.S. and EU.

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