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EU, US agree pharmaceuticals mutual recognition

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EU, US agree pharmaceuticals mutual recognition

Drugs

(BRUSSELS) - The EU and the United States have completed a Mutual Recognition Agreement, with both sides agreeing to reduce barriers and increase trade in pharmaceuticals as part of ongoing EU-U.S. trade talks.

Last week's recognition by the U.S. Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, marked 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 is expected to make it faster and less costly for both sides to bring medicines to the market.

The agreement would ensure high quality medicines for the benefit of patients, assured the EU's Commissioner in charge of Health and Food Safety,Vytenis Andriukaiti: "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."

The U.S. Food and Drug Administration has now completed the capability assessments of the 28 EU competent authorities.

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, the Commission says 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.

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 EU executive, 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.

From now on, a batch testing waiver will start to apply. This means that qualified persons in the EU pharmaceutical company will be relieved of their task for carrying out the quality controls when carried out already in the United States.

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

2017 marked the entry into operation of an agreement between the EU and the U.S. to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement strengthens reliance upon each other's inspection expertise and resources. Initially it applied between the U.S. Food and Drug Administration and those EU Member States that the U.S. Food and Drug Administration had assessed. This has been gradually extended to all EU countries and now the regulatory authorities in all 28 EU Member States were recognised by the U.S. Food and Drug Administration. Meanwhile, the EU made the same determination about U.S. Food and Drug Administration in June 2017.

Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 11 July 2019


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