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FDA and EMA fully implement mutual recognition agreement between US and EU

Published on 15/07/19 at 10:49am

The FDA has recognised Slovakia’s ability to carry out inspections of manufacturing facilties.

The recognition of Slovakia marks the full implementation of the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines between the United States and the European Union.

Guido Rasi, Executive Director of the EMA, commented: “We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results.

“This milestone is a testimony to the importance of our strategic partnership with the US. It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured”

Under the MRA European and American regulators will now rely on each other’s results to ensure that manufacturing facilities are operating in compliance with good manufacturing practice (GMP).

It is hoped that the MRA will free up regulators' time to focus on countries outside of the United States and the EU.

While the MRA between the EU and the US was first signed in 1998, it has not been fully implemented. The recognition of Slovakia comes as the final step towards full recognition of all EU member states.

Louis Goss

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