U.S./EU drug agency collaboration
This article was originally published in The Tan Sheet
Executive Summary
FDA and the European Medicines Agency extend their confidentiality arrangement related to medicinal products indefinitely "without the need for further renewal," EMA announces Sept. 15. The collaboration allows the agencies to exchange confidential information as part of their regulatory and scientific processes, including scientific advice and data on good manufacturing practice and good clinical practice inspection reports, marketing authorization procedures and post-marketing surveillance. The extension follows their initial deal signed in 2003