The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed between them.
The agreement will allow the European Medicines Agency (EMA) to use data from US Food and Drug Administration (FDA) inspections and vice versa from November.
It also means EU authorities will only visit US sites in exceptional circumstances.
According to the European Commission the agreement “facilitates the exchange of official GMPs documents” and enables “reliance on the factual findings in such documents.”
The Commission also said it will allow national competent authorities from EU Member States which conduct inspections under EMA guidance and the US FDA to make better use of inspection resources and avoid duplicate site visits.
It also added that “The enhanced cooperation with US regulatory authorities will improve the EU’s ability to identify and address problems at factories before they become a public health risk.
“It will also reduce the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers.”
The deal builds on the EU-US Mutual Recognition Agreement (MRA) signed in 1998..
For details Agreement draft attached..