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. On 26 June 2019, the US Food and Drug Administration (FDA) confirmed the capability of Germany to carry out good manufacturing practice (GMP) inspections at a level equivalent to that of the US. There are now a total of 27 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 the first eight of the EU Member States: Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. Since then, the FDA have continued their inspections and have now confirmed the capability of 27 of the 28 EU Member States, with only Slovakia still to be assessed.

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.

More information:

• Updated List of recognised countries
• EMA website