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

01-05-2019

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

(Source: EMA 2019-05-02)

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019. 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 24 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.

Actions for the agreement to be operational in all EU Member States are progressing. The planned date of operation is 15 July 2019.The mutual recognition agreement between EU and US regulators strengthens reliance on each other's inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:

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