EMA Updates Q&A on EU–US Mutual Recognition Agreement

The European Medicines Agency (EMA) has revised its Q&A document on the Mutual Recognition Agreement (MRA) between the EU and the US. The update clarifies reliance on U.S. FDA inspections conducted outside the United States. As of 1 October 2025, following a pilot program evaluation, the EU GMP/GDP Inspectors Working Group agreed to apply Article 3(1) of the MRA, allowing voluntary reliance on such inspections. Additional updates reflect progress in veterinary medicine oversight, confirming the inspection capabilities of Cyprus, Czechia, Slovakia, Italy, and Romania, while assessments for Malta and Croatia continue. The revised document also updates expectations for the veterinary batch testing waiver, now projected for Q1 2025, with further guidance to follow.

27-10-2025