Germany Joins EU-US GMP Mutual Recognition Pact
On Thursday, the European Medicines Agency (EMA) and European Commission (EC) announced that Germany has joined the mutual recognition agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states.According to the two agencies, FDA confirmed that Germany’s GMP inspections are “at a level equivalent to that of the US.”
The announcement comes just weeks after Luxembourg and the Netherlands were added to the agreement and two months after Bulgaria and Cyprus joined the pact.
With the addition of Germany, the agreement now covers inspections carried out by regulators from all EU member states except Slovakia.
EMA notes that “actions for the agreement to be operational in all EU member states are progressing” ahead of the agreement’s planned 15 July date of operation.
Under the terms of the agreement signed in 2017, the agreement may be terminated if FDA has not completed an assessment of each EU member state by 15 July 2019, though that date may be extended based on when the EU regulator’s capability assessment packages were submitted to FDA for review.
EMA, EC