The European Commission and the United States Food and Drug Administration (FDA) have updated the EU-US 1998 Mutual Recognition Agreement (MRA). According to this amendment, the EU and US regulatory authorities now mutually recognize inspections of pharmaceutical manufacturing facilities.

The aim of this MRA is to avoid the duplication of inspections, to lower inspection costs and to enable regulators to devote more resources to other parts of the world where there may be greater risk.

The MRA states that by November 2017, FDA must have assessed authorities in eight EU countries and that FDA’s assessment of all of the EU national agencies has to be completed by July 15th 2019.

Share This