Ireland and Lithuania to benefit from EU-US mutual recognition agreement for GMP inspections

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. Lithuania and Ireland have been confirmed by the United States (US) Food and Drug Administration (FDA) as two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US.

There are now 14 Member States whose inspection results the FDA can rely on to replace their own inspections. Plans for the agreement to be operational in all EU Member States by 15th July 2019 are on track.

The European Commission has confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. The FDA confirmed the capability of eight EU Member States on 1st November 2017. Four additional EU Member States were recognised by the FDA on 1st March 2018.

The mutual recognition agreement between EU and US regulators helps strengthen the reliance on each other’s inspection expertise and resources. There are several mutual benefits for EU authorities and the FDA, including prioritising inspections of medicines manufacturing sites for higher risk cases and improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk.

To read more about the benefits of the EU-US mutual recognition agreement for GMP inspections, please click here.