Thursday, 19 September 2019

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


With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.

Each 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 and hence avoid duplicative work. As a result of the MRA, both the EU and the US will be able to free up resources to inspect facilities in other countries.


The MRA 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, EMA and the FDA 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.

From now on, 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 US when these controls have already been carried out in the US. 

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

See:  https://www.ema.europa.eu/en/news/eu-us-reach-milestone-mutual-recognition-inspections-medicines-manufacturers

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

1 comment:

  1. I really hope that this agreement will lead to a drug shortage reduction both in EU and in US. It's a huge problem worldwide and only by collaborating between countries and spreading awareness we can find a solution. It should save many patients so these news are really great!

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