EU and US reach milestone in mutual recognition of medicines manufacturers inspections

The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. 

Every year, EU national authorities and the U.S. 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. The EU and the US are also examining how to uniformly implement relying on conclusions of inspections in third countries.

Prior audits and assessments

The MRA is underpinned by robust evidence on both sides of the Atlantic that the EU and the US use comparable procedures to carry out GMP inspections for human medicines. Since May 2014, teams from the European Commission, the EU national competent authorities, the European Medicines Agency (EMA) and the U.S. FDA have audited and assessed their respective supervisory systems. The Belgian Federal Agency for Medicines and Health Products (FAMHP) was officially positively assessed on 9 August 2018.

Quicker batch release

From now on, a batch testing waiver will also start to apply. This means that the qualified persons (QP) in EU pharmaceutical companies will no longer have to carry out quality controls for products manufactured in and imported from the US when these controls have already been carried out in the US. The QP will therefore be able to carry out its batch release more quickly.

The implementation of the MRA will continue with a view to expanding the operational scope to veterinary medicines, human vaccines and plasma-derived medicinal products.

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

Last updated on
31/07/2019