Regulators in the EU and the US have signed a transatlantic agreement to recognise inspections of manufacturing sites for human medicines carried out in their respective countries.
Under the new deal, regulators on both sides of the Atlantic will now rely on each other’s inspections in their own territories to ensure that sites operate in compliance with Good Manufacturing Practice (GMP), to optimise use of capacity and reduce duplication.
The agreement follows robust evidence that EU and US systems have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.
The move will enable both EU authorities and the US Food and Drug Administration to hone their focus on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured, to ensure their quality, safety and efficacy.
Around forty percent of finished medicines marketed in the EU come from overseas and 80 percent of the manufacturers of APIs for medicines available in the EU are located outside the Union.
According to the European Commission: “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”.
