Two additional countries to benefit from EU-US mutual recognition agreement for inspections


11 June 2019 - On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union and the United States FDA. 

The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice inspections at a level equivalent to the United States (US). The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 26 Member States whose inspection results can 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 EMA can rely on inspection results from the FDA.

Read EMA press release

Michael Wonder

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Michael Wonder