Poland and Slovenia Added to EU–US Mutual Recognition Agreement

February 15, 2019

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

On Feb. 11, 2019, the European Medicines Agency (EMA) announced that Poland and Slovenia have been included into the mutual recognition agreement between the European Union and the United States to carry out US-level GMP inspections at European facilities. The agreement recognizes pharmaceutical manufacturing facility inspections conducted in different territories. FDA and EMA can then rely on those inspections results and avoid duplicate efforts.

The agreement allows the EU and the US to focus its resources on other parts of the world and prioritize on higher-risk sites. It also reduces administrative burdens and costs that would be incurred by duplicate inspections.

With the addition of Poland and Slovenia, the total number of EU countries involved in the agreement is now at 22 Member States. It is anticipated that all EU Member States will be involved by July 15, 2019.

Source: EMA