Mra Agreement Gmp
In July 2018, President Juncker and Trump agreed on a joint declaration. These included the commitment of the EU and the US to reduce barriers and increase trade in a number of sectors, including pharmaceuticals. A key element of the Joint Statement was provided with the implementation of the Mutual Recognition Agreement (MRA) for site inspections, when the last outstanding EU Member State was recognised by the US Food and Drug Administration (FDA) on 11 July 2019. The MUTUAL Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from drug inspections conducted within the borders of the other country. Under the Food and Drug Administration Safety and Innovation Act, passed in 2012, the FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA finds that those authorities are able to conduct inspections that meet U.S. requirements. . . .