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EMA Defers U.S. GMP Inspections Pending November Activation of Mutual Agreement

July 12, 2017

The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed this week, in anticipation of the November launch of a mutual agreement between the EU and U.S.

The agreement, signed in March, will take some pressure off both agencies when it comes to international inspections starting Nov. 1. But in the meantime, visits will slow or even stop while the parallel agencies asses each other’s inspection capabilities.

A pre-existing mutual reliance initiative between EU authorities and the FDA is already used to defer some EU inspections in the U.S. based on a risk assessment.

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