Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 8 February 2019 (updated)

11 février 2019

BlueRegWatch

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Poland and Slovenia were included into the mutual recognition agreement between the EU and the US on 7 February 2019. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 22 Member States whose inspection results can replace their own inspections.

BlueRegWatch

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