Five Additional EU Member States Able to Perform GMP Inspections Equivalent to US Level

November 30, 2018

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United States, it was revealed in Nov. 29, 2018 news story from the European Medicines Agency (EMA).

On Nov. 16, 2018, Belgium, Denmark, Finland, and Latvia, and Nov. 28, 2018, Estonia, were included in the mutual recognition agreement (MRA) currently in place between the European Union and the US. The MRA allows for the mutual recognition of manufacturing site inspections for human medicines that are conducted within the relevant territories. With the latest five additions, the FDA will be able to rely on a total of 20 EU member states for inspection results.

Since Nov. 1, 2017, European member states as well as EMA have been able to rely on GMP inspections carried out by FDA. Furthermore, the plans for all EU member states to be included within the EU-US MRA by July 15, 2019, have been reported as ‘on track’. 

Source: EMA