Two more countries Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for inspections

The US Food and Drug Administration (FDA) confirmed the capability of two additional European Union (EU) Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019.

The agreement mutually recognises 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 24 Member States whose inspection results can replace their own inspections.

EMA said, “The mutual recognition 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 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.

As of now, Germany, Luxembourg, The Netherlands and Slovakia are the only EU member states that have yet to be added to the mutual recognition agreement.

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