EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated

The Questions & Answers document on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States was updated.

What was changed compared to the previous version?

Clarification/ new phrasing about reliance on inspections outside US was added (Q3): "Following an evaluation through a pilot programme the EU GMP/GDP Inspectors Working Group agreed to enable the voluntary provision of the EU-US MRA foreseen in Article 3(1) of the agreement to rely on the outcome of US FDA inspections conducted outside the US as of 1 October 2025". The older version's Q3 was less forward-dated about when reliance on inspections outside the US might be applied.

Other adjustments were due to developments in the veterinary medicine sector. The capability of more EU Member States was confirmed (Cyprus, Czechia, Slovakia, Italy and Romania). The assessments of the now remaining two EU Member States (Malta and Croatia) for inspections of manufacturers of veterinary products are ongoing.
There is also a shift in timeline expectations for veterinary batch testing waiver (Q11): "Currently this is estimated to be by Q1/2025. Further guidance on this topic will be published in due course."