United States and Europe Reach Milestone Agreement on Mutual Recognition of Inspections

European Parlement

The European Union and the United States have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing of (bio-) pharmaceutical sites for certain human medicines in their respective territories. The agreement was implemented after the recognition by the United States Food and Drug Administration (FDA) of Slovakia as a partner in the agreement.

“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 United States,” said Guido Rasi, Executive Director of European Medicines Agency, the European counterpart of the FDA in charge of the scientific evaluation, supervision and safety monitoring of medicinal products withing the territory of the European Union.

“[The partnership with the United States] 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,” Rasi added.

Good Manufacturing Practice
Each year, European national authorities and the FDA inspect many production sites of medicinal products in the European Union, the United States and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP).

Under the mutual recognition agreement , European Union and American regulators will now rely on each other’s inspections for human medicines in their own territories and, as a result, avoid duplicative work. The mutual recognition agreement helps free up resources so that inspecition teams from the European Union and the United States can inspect facilities in other countries.

Robust evidence
The mutual recognition agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable procedures to carry out GMP inspections for human medicines.

Since May 2014, teams from the European Commission, the EU national competent authorities, European Medicines Agency and the Food and Drug Administration have been auditing and assessing the respective supervisory systems. With the positive assessment of Slovakia, this process has now concluded for GMP inspectorates covering human medicines.

In addition to the mutual recognition agreement, a batch testing waiver will also start to apply. This means that the qualified persons in EU pharmaceutical companies will no longer have to carry out quality controls for products manufactured in and imported from the United States when these controls have already been carried out in there..

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

Background
In 1998, the EU and the US signed a broad MRA, which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s GMP inspections. However, this Agreement was never fully implemented.

The European Union and the Food and Drug Administration began talks in 2014 which resulted in the revision of the Annex in 2017. based on the negotiations, November 1, 2017 marked the entry into operation of the agreement between the EU and the US to recognize inspections of manufacturing sites for human medicines conducted in their respective territories.

The agreement strengthens reliance upon each other’s inspection expertise and resources. Initially it applied between the Food and Drug Administration and select EU Member States that the FDA had assessed. This has been gradually extended to all EU Member States. Similarly, the EU assessed its counterpart in the US, concluding in June 2017 that the FDA has the capability, capacity and procedures in place to carry out GMP inspections for human medicines at a level equivalent to the EU.

In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU Member States. The European Medicines Agency plays an important role in coordinating these activities in collaboration with the Member States in particular for centrally authorized products.