Batch testing requirements lifted by U.S.-EU GMP agreement signed in late June.
This article was originally published in The Tan Sheet
Executive Summary
EUROPEAN BATCH TESTING REQUIREMENT TO BE DROPPED IN THREE YEARS under the final mutual recognition agreement on Good Manufacturing Practices signed by the U.S. and European Union June 20. Under the agreement, companies will not be required to conduct point-of-entry batch testing, "provided that these controls have been carried out in the U.S. and that each batch/lot is accompanied by a batch certificate...issued by the manufacturer certifying that the product complies with the requirements of the marketing authorization."