Luxembourg and The Netherlands Next in Line To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines
Luxembourg and The Netherlands have become the 25th and 26th EU Member State able to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US. The US Food and Drug Administration (“FDA”) confirmed as much on 10 June 2019. As a result, Luxembourg and The Netherlands now form part of 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. There are now just two more Member States left for assessment and this process is anticipated to be completed on 15 July 2019.
The latest announcement of the European Medicines Agency ("EMA") on the subject can be found here: https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-1.
The EMA also updated again its Questions and Answers document on the impact of the MRA: https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-10-june_en.pdf.