EU/U.S. MRA cannot include public access to inspection reports, EC administrator contends.

Executive Summary

GMP INSPECTIONS REPORT PUBLIC ACCESS UNDER MRA OPPOSED BY EU, European Commission Administrator Gudrun Gallhoff told the University of Texas International Industrial Pharmacy Conference Feb. 26 in Austin, Tex. "We have agreed to deliver those reports, taking the burden on us of translating those reports as necessary and giving them to the U.S. government," Gallhoff stated. "What we cannot agree to is that those reports go public, because it's against the law of several member states." FDA's lead negotiator on the MRA, International Affairs Director Walter Batts, acknowledged that public availability of information in inspection reports "remains an issue."