FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

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

March 9, 2017
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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.

Under the terms of the agreement, national agencies will recognize one another’s inspection results and GMP documents for facilities within their jurisdictions. The regulators can opt out of accepting documents if the inspection reports contain material inconsistencies, inadequacies or quality defects in the post-market surveillance.

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