New transatlantic agreement on mutual recognition of inspections

03 March 2017

The EU and the USA 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 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 US 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.

In the opinion of the Danish Medicines Agency, this agreement is a major improvement. ”With this agreement, we avoid duplication that will benefit both the authorities and manufacturers. At the Danish Medicines Agency, we will be able to use our inspection resources in a better way and focus on the areas in which we see the greatest risks,” says Merete Hermann, Director of Division of Medicines Control & Inspection.

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.


The European Medicines Agency’s press release