Agreement now operational between 26 EU Member States and the US Food and Drug Administration

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 on 10 June 2019 the capability of two additional EU Member States (The Netherlands and Luxembourg) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 26 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: Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom in November 2017. Czech Republic, Greece, Hungary, and Romania were recognised by the FDA on 1 March 2018, Ireland and Lithuania on 1 June 2018, Portugal in September 2018, Belgium, Denmark, Estonia, Finland and Latvia in November 2018, Poland and Slovenia in February 2019 and Bulgaria and Cyprus in April 2019. Two more Member States remain 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: 

• EMA website