Agreement now operational between 20 EU Member States and FDA
The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. In November 2018, the US Food and Drug Administration (FDA) confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement on 16 November and Estonia on 28 November 2018. As from this day, the FDA will rely on a total of 20 Member States whose inspection results can replace their own inspections.
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, EU Member States and the European Medicines Agency (EMA) can rely on inspection results from the FDA. The mutual recognition agreement between EU and US regulators strengthens reliance on each other’s inspections expertise and resources.
Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.
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 European Commission, 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.