Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration, effective June 10.
The FDA thus confirmed the capability of these two additional EU member states to carry out Good Manufacturing Practice (GMP) inspections at a level equivalent to the USA. The agreement mutually recognizes inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 26 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 November 1, 2017, EU member states and the European Medicines Agency 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 July 15, 2019. The agreement between EU and US regulators strengthens reliance on each other’s inspection expertise and resources.
The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the USA have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, the 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.