U.S., E.U. Agree on Mutual Recognition of Drug Manufacturing Inspections

FDAnews Drug Daily Bulletin reports that “After almost three years of negotiations, the U.S. and the European Union have agreed to recognize each other’s drug GMP inspections. The new pact amends the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement, to avoid duplication and cut costs for inspections”. Click here for the full but brief story and down below for the FDA’s full press release.

The corresponding FDA News Release reports that “In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections.” Click here to read the full release.

Contact us if you need assistance preparing for a Pre-Approval Inspection.