Recognition of the FAMHP by FDA

Recognition of the FAMHP by FDA

Europe The FDA has recognized all 28 EU member states. This means that starting 11 July 2019, the US and the EU have fully implemented the mutual recognition agreement (MRA).  Every year, EU national authorities and the FDA inspect many production sites of...

Update of MRA between EU and US

EU 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...