U.S.-EU Inspection Agreement Includes Two New EU Members
The Netherlands and Luxembourg are now included in the mutual recognition agreement forged between the U.S. and the EU on GMP inspections.
The recognition means the two countries can now be counted on to conduct inspections that are on par with the FDA’s. The European Medicines Agency says it’s “on track” for the agreement to become operational in all EU member states by July 15.
The mutual recognition pact aims to cut duplicate inspections, so agencies can move some of their inspection resources to other countries that manufacture drugs and APIs for the U.S. and EU.