EU-U.S. trade talks: milestone reached in mutual recognition on pharmaceuticals

The positive transatlantic trade agenda established in the Joint Statement includes a commitment from both sides to reduce barriers and increase trade in a range of sectors, including pharmaceuticals.

The recognition by the U.S. Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, marks the full implementation of the EU-U.S. Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for human medicines in their respective territories. This can make it faster and less costly for both sides to bring medicines to the market.

This Mutual Recognition Agreement is underpinned by robust evidence that the EU and the U.S. have comparable procedures to carry out good manufacturing practice inspections for human medicines.

Global sales

Together, Europe and the United States account for more than 80% of global sales of new medicines. As a result of the full implementation of this agreement, both the industry and public authorities on both sides will be able to free resources that could be used to inspect facilities in other large producing countries.

Strategic sector

The pharmaceutical industry is a strategic sector in which EU-U.S. regulatory cooperation is much more advanced than in most other sectors. Since May 2014, teams from the European Commission, EU national competent authorities, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration have been auditing and assessing the respective supervisory systems. The U.S. Food and Drug Administration has now assessed positively all national competent authorities of the EU.

The Mutual Recognition Agreement implementation work will continue with view to expanding the operational scope to veterinary medicines, human vaccines and plasma derived medicinal products.

Background

In 1998, the EU and the U.S. signed a broad Mutual Recognition Agreement, which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practices (GMP) inspections.

2017 marked the entry into operation of the agreement between the EU and the U.S. to recognise inspections of manufacturing sites for human medicines conducted in their respective territories.

For More Information

European Medicines Agency (EMA): Press release and Q&A