Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

The United States and European Union announced on Thursday they have agreed to mutually recognize each other's good manufacturing practice inspections of pharmaceutical manufacturing facilities.

The United States and European Union announced on Thursday they have agreed to mutually recognize each other's good manufacturing practice inspections of pharmaceutical manufacturing facilities. The agreement to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement will enable FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other's borders. This will help to avoid duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other areas of the world where they may be greater risk. "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 safe, effective, and high-quality drugs," said Dara Corrigan, FDA's associate commissioner for global regulatory policy.