BRIEF—FDA and Swissmedic to share each other's GMP inspectional finding

The US Food and Drug Administration (FDA) says sit has signed the Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice.

By signing such an agreement, with the Swiss Confederation (Switzerland), the FDA and the Swiss Agency for Therapeutic Products (Swissmedic) will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

The Food and Drug Administration Safety and Innovation Act, enacted in 2012, permitted the FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet U.S. requirements.

The FDA already has a Mutual Recognition Agreement (MRA) in place with the European Union and one with the UK.

In addition to covering good manufacturing practice inspections of facilities making human drugs, the MRA with Swissmedic also includes veterinary drugs.