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Europe Daily Bulletin No. 12295

13 July 2019
Contents Publication in full By article 14 / 27
EXTERNAL ACTION / United states
Mutual Recognition Agreement on pharmaceutical inspections finalised
Brussels, 12/07/2019 (Agence Europe)

It took the US Food and Drug Administration (FDA) 5 years to complete capability assessments of the 28 EU Member States under a transatlantic Mutual Recognition Agreement (MRA) for pharmaceuticals. With the FDA’s recognition of Slovakia on Thursday, 11 July, this has been done: all regulatory authorities of the Twenty-Eight are now recognised by the FDA - which has been reciprocal since June 2017 when the EU determined the same about the FDA.

Rather than having to carry out their own...

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