Posted by Michael Wonder on 02 Mar 2017
European and US regulators agree on mutual recognition of inspections of medicines manufacturers
2 March 2017 - Transatlantic agreement will help to make better use of inspection capacity and reduce duplication
Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
Each year, national competent authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s inspections in their own territories. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances.
