GMP inspection report to be exchanged indefinitely under U.S.-EU MRA agreement.
This article was originally published in The Tan Sheet
Executive Summary
GMP INSPECTION REPORTS WILL BE EXCHANGED THROUGHOUT U.S.-EU MRA with the caveat that Good Manufacturing Practices reinspections will be rare. The decision on inspection reports exchange came about through a U.S.-European Union mutual recognition agreement-in-principle thrashed out by industry and government reps at a Transatlantic Business Dialogue (TABD) meeting in Chicago Nov. 9.