Luxembourg, Netherlands Join EU-US Mutual Recognition Agreement for GMP Inspections

By Emily Forster -

June 12, 2019

Luxembourg and the Netherlands have joined the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) inspections. The FDA has confirmed the capability of these two additional EU member states to carry out GMP inspections at a level equivalent to the US. 

The agreement mutually recognizes the inspections of manufacturing sites for human medicines conducted in the different territories, meaning the FDA can now rely on a total of 26 EU member states whose inspection results can replace the agency’s own inspections.

In June 2017, the European Commission confirmed the FDA could carry out GMP inspections at a level equivalent to the EU. As of November 1, 2017, EU member states and the European Medicines Agency (EMA) could 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 for the agreement is July 15, 2019. Teams from the European Commission, EU national authorities, the EMA and the FDA have been auditing and assessing the supervisory systems since May 2014 to reach the agreement’s milestones.

Source: EMA