The FDA has recognized all 28 EU member states. This means that starting 11 July 2019, the US and the EU have fully implemented the mutual recognition agreement (MRA). 

Every year, EU national authorities and the FDA inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the MRA, EU and US regulators will now rely on each other’s inspections for human medicines in their own territories. Hence, they’ll avoid duplicative work, meaning the EU and the US agencies will be able to free up resources to inspect facilities in other countries.

Quicker batch release

As of 11 July 2019, qualified persons (QP) in EU member states no longer need to batch test human medicinal products manufactured in and imported from the US when these tests have already been carried out in the US.

Of note, this MRA does not (yet) apply to veterinary medicines, vaccines for human use and plasma-derived medicines. Also the investigational medicinal products might be added to the scope in a later stage.

More information can be found on the website of the EMA.


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