Slovakia Final Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines
Slovakia has become the 28th and final EU Member State to be given the powers to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US (see attached press release). On 11 July 2019, the US Food and Drug Administration (“FDA”) confirmed Slovakia’s status under the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. For their part, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017.
Pursuant to the MRA, the EU and the US now fully recognise inspections of manufacturing sites for human medicines carried out in each other’s territories. Separately, the batch testing waiver existing under the MRA will also start to apply. As a result, qualified persons in pharmaceutical firms based in Europe will no longer be required to carry out the quality controls when these have already been run in the US.
The EU and US will continue implementation work for the MRA in hopes of extending its scope to a range of additional products, including veterinary medicines, human vaccines and plasma derived medicinal products.