FDA – EMA mutual recognition of inspections of medicines manufacturers enters operational phase

FDA & EMA

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in placeExternal link icon to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. Today, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.

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