EU and U.S. agree on inspections of manufacturing sites for human medicines
Each year, national competent authorities from the USA and the EU inspect production sites of medicinal products in the EU, the USA and elsewhere in the world.
The purpose of the inspections is to ensure that these sites operate in compliance with good manufacturing practice (GMP).
Under the new agreement, EU and U.S. regulators will rely on each other’s inspections in their own territories.
This means that the need for an EU authority to inspect a site located in the USA, or vice versa, will be limited to exceptional circumstances. The agreement is expected to enter into force in November.
The agreement will enable the EU member states and the USA to make better use of their inspection resources in other parts of the world where medicines for the EU or US markets are manufactured.
Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union. ■