The document published on 1 October 2025 by the EMA Inspections Office updates the Questions & Answers on the impact of the Mutual Recognition Agreement (MRA) between the European Union and the United States.
Question 1 has been updated with regard to GMP inspections of veterinary products. Specifically, between June 2023 and September 2025 the FDA confirmed the capability of Sweden, Latvia, Lithuania, Germany, Cyprus, Czech Republic, Slovakia, Italy and Romania. Assessments of Malta and Croatia for inspections of manufacturers of veterinary products are ongoing.
Q3 now states that, on the basis of a pilot programme, the EU GMP/GDP Inspectors Working Group has agreed to enable the voluntary provision of the EU-US MRA, as set out 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.
According to the new Q11, the batch testing provision for veterinary products will be implemented once the FDA has recognised all the EU National Competent Authorities responsible for veterinary medicinal products. This is expected to be completed by Q1/2025. Further guidance on this topic will be published in due cours