U.S., EU to share pharma inspection reports

Abstract

U.S. and European Union regulators have agreed to recognize each other’s inspection reports of pharmaceutical manufacturing facilities. The decision is expected to help FDA and EU drug inspectors avoid duplicating inspections. It’s also expected to lower inspection costs and help regulators focus resources in parts of the world where the risk of unsafe drugs is the greatest. The agreement comes after nearly three years of collaboration between FDA and EU inspectors to assess the risks and benefits of relying on foreign inspections of drug manufacturing facilities. Congress gave FDA the authority to use foreign drug inspection reports in 2012 with the passage of the FDA Safety & Innovation Act. The law allows FDA to recognize foreign inspections as long as those inspections meet U.S. requirements. “The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to