On 26 June 2019, Germany was included in the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognizes inspections of manufacturing sites for human medicines conducted in different territories.
In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1 November 2017, the EU Member States and EMA can rely on inspection results from the FDA.
Actions for the agreement to be operational in all EU Member States are progressing. The planned date of operation is 15 July 2019. The mutual recognition agreement between EU and US regulators strengthens reliance on each other’s inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:
The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the EC, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and are working closely together to reach the agreement’s milestones.