Portugal to Benefit from EU-US Mutual Recognition Agreement for Inspections

September 20, 2018

The agreement now includes 15 European Union (EU) member states.

On Sept. 20, 2018, the European Medicines Agency (EMA) reported that the mutual recognition agreement between the European Union (EU) and the United States to recognize inspections of pharmaceutical manufacturing sites conducted in their respective territories now includes Portugal. FDA confirmed in September 2018 that one additional EU member state (Portugal) was able to carry out GMP inspections at the same level as the US. The addition of Portugal to this agreement brings the total of member states whose inspection results can be relied on to replace FDA’s own inspections to 15.

In June 2017, the European Commission (EC) confirmed that FDA “…has the capability, capacity, and procedures in place to carry out GMP inspections at a level equivalent to the EU”. Since November 2017, EU member states and EMA can rely on inspection results from FDA to replace their own inspections; that same month, FDA confirmed the capability of eight EU member states: Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom. In March 2018, FDA also confirmed Greece, Hungary, Czech Republic, and Romania, as well as Ireland and Lithuania in June 2018.

EMA states that plans for the agreement to be operational in all EU member states by July 15, 2019 are on track, and that the agreement is supported by evidence that both the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission (EC), EU national competent authorities, EMA, and FDA have been auditing and assessing the respective supervisory systems since May 2014 and are working closely together to reach the agreement’s milestones, according to EMA.

Source: EMA