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Trade | Brussels, 2 March 2017

Commission adopts updated EU-US agreement on mutual recognition of inspections of medicine manufacturers

The European Commission and the United States Food and Drug Administration have adopted an agreement to mutually recognise inspections of premises where medicines are produced.

With this update of the 1998 Agreement on good manufacturing practices, EU and US regulatory authorities will be able to rely on each other’s information as regards facilities in the EU or US that manufacture medicines and active pharmaceutical ingredients for the European and American markets. The agreement will not affect the process of approving medicines, as it focuses only on inspections of manufacturing sites. 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 updated agreement is a result of successful cooperation between the European Commission, the European Medicines Agency and the US Food and Drug Administration. It now enters into force following the signature by both Parties, while the recognition of inspections can apply as early as November of this year.

The full text of the agreement is available here (also available in DE and FR).