Join us at this years Regulatory Affairs Summit in Prague, 24-26 October, 2017October 06, 2017
European and US regulators agree on mutual recognition of inspections of medicines manufacturers
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 AdministrationExternal link icon (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.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. 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.
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