Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

1 June 2018

Agreement now operational between 14 EU Member States and FDA

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. The US Food and Drug Administration (FDA) confirmed the capability of two additional EU Member States (Lithuania and Ireland) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 14 Member States whose inspection results the FDA can rely on to 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 1 November 2017, EU Member States and the European Medicines Agency (EMA) can rely on inspection results from the FDA to replace their own inspections. On 1 November 2017, the FDA confirmed the capability of eight EU Member States. Four further EU Member States were recognised by the FDA on 1 March 2018.

Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.

Each year, EU national authorities and the FDA inspect many manufacturing sites of medicines in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with GMP. Around 40% of finished medicines marketed in the EU come from overseas and, for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union.

The mutual recognition agreement between EU and US regulators strengthens reliance on each other's inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:

• the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
• prioritising inspections of medicines manufacturing sites for higher risk cases;
• reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
• improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk;
• reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.

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.