Bulgaria and Cyprus Also To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines
The European Medicines Agency (“EMA”) announced on 30 April 2019 that the US Food and Drug Administration (“FDA”) just added Bulgaria and Cyprus to the list of EU Member States able to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US. As a result, Bulgaria and Cyprus now form part of the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. There are at present 24 EU Member States whose inspection results can replace those of the FDA. Conversely, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017.
It is expected that the MRA will be operational in all EU Member States on 15 July 2019.
The EMA updated its Questions & 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-30-april_en.pdf.