Mutual recognition agreement for inspections (MRA): The Netherlands and Luxembourg to also benefit from EU-US MRA

11 juin 2019

BlueRegWatch

The mutual recognition agreement between the EU and US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US Food and Drug Administration (FDA) confirmed on 10 June 2019 the capability of The Netherlands and Luxembourg to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 26 Member States whose inspection results the FDA can rely on to replace their own inspections.

BlueRegWatch

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