Since 1 November 2017, the EU–US MRA on Good Manufacturing Practice (GMP) inspections has been in effect. Under this agreement, the EU and US mutually recognise each other’s GMP inspections, however,EU authorities have largely relied on FDA inspections of sites located within the US or on inspections conducted by EU Member State inspectorates.

Following a successful Pilot program announced in 2023, EU authorities may now also voluntarily rely on FDA inspections conducted outside the US. These are based on case-by-case risk assessments and proactive sharing of inspection reports by applicants. By recognising FDA inspection outcomes from third countries, EU regulators can reduce duplication of inspection activity and focus their inspection efforts on higher-risk or previously less-inspected sites. The ability to rely on such inspection results supports more efficient global regulatory oversight and aligns with broader efforts to manage risk across pharmaceutical supply chains.

In May 2023, the MRA was extended to veterinary products, after the EU confirmed the FDA’s equivalence for veterinary GMP inspections. In the future, the scope of the agreement may extend to vaccines, plasma-derived, and investigational products after further evaluations.

Overall, this development enables the EU to recognise even broader FDA inspection outcomes, thereby advancing efficiency, trust-based oversight and global supply-chain resilience, while retaining the rigour and sovereignty of regulatory decision-making.

Related articles
EU and Brazil health authorities enter partnership

Global harmonization of GMP standards for biologicals 

Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP

Reference
1. questions-and-answers-impact-mutual-recognition-agreement-between-european-union-and-united-states-7-August-2024_en (1)

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2026 Pro Pharma Communications International. All Rights Reserved.