EU-US mutual medicines inspection agreement now operational

Today, November 1, marks the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States to recognize 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 has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU.