MRA with FDA: Two new States accepted

Recommendation

27/28 October 2021

GMP for Medical Devices - EU versus USA - Live Online

After a positive assessment, the US Food and Drug Administration (FDA) has approved Lithuania and Ireland to be fully covered by the current EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers. They are now also "recognised as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines".

The total number of countries accepted by the FDA is now 14: Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Hungary, Romania plus Lithuania and Ireland.

Other EU member states will be added as their evaluation is completed by the US. According to an older EMA press release, "Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track."