Germany Latest Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines
- 01/07/2019
- Articles
Germany has become the 27th 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 this on 26 June 2019. As a result, Germany now forms 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 is now just the Slovakia left for assessment and this is expected to happen by 15 July 2019.
The latest announcement of the European Medicines Agency on the subject can be found here:
https://www.ema.europa.eu/en/news/one-additional-country-benefit-eu-us-mutual-recognition-agreement-inspections.
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-27-june_en.pdf.
