With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for medicines in their respective territories. This is a milestone as it avoids duplicative work. In the past, EU national authorities had to carry out quality controls for products manufactured in and imported from the US although these controls have already been carried out by the FDA in the US. As both authorities work based on comparable procedures (GMP) it was already decided in year 1998 to sign the MRA. However, the agreement was never fully implemented until today.
EU and US: Mutual recognition of inspections of API manufacturers
