The first attempt for the EU and the USA to have a GMP MRA for medicinal products dates back to 1998, when the first MRA was signed between the two parties.
First announced in March 2017, the mutual recognition agreement (MRA) for Good Manufacturing Practices (GMP) for medicinal products between the European Union (EU) and the United States of America (USA) is now fully implemented.
In this White Paper, we summarize the scope and the impact of this agreement on the pharmaceutical manufacturers and the authorities in both regions.