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


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The European Union and the United States delivered on a significant element of the Joint Statement agreed by Presidents Juncker and Trump in July 2018. 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 today 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.

Commissioner Vytenis Andriukaitis, in charge of Health and Food Safety said: "The completion of the Mutual Recognition Agreement is not only a step forward in the trade relations between the EU and the U.S., but it will also ensure high quality medicines for the benefit of patients. It means that, on both sides of the Atlantic, the authorities in charge of medicines can now rely on inspections results to replace their own inspections. Today, the U.S. Food and Drug Administration has completed the capability assessments of the 28 EU competent authorities, the result of five years of close transatlantic cooperation”.

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.

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.

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