The United States and the European Union (EU) amended the 1998 U.S.-EU Mutual Recognition Agreement for Pharmaceutical Inspections. The US and the EU will now be able to use each other’s inspections of pharmaceutical manufacturers which will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
Since May 2014, the FDA and the EU have been evaluating the way they each inspect drug manufacturers.. The FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the regulatory authority of another EU country.