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."
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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." Industry is said to be disappointed with the MRA batch testing provisions, having urged that the requirement be lifted immediately upon signing the agreement instead of after a three-year transition period. Another industry concern is the extent to which the provisions of the MRA will be subject to amendment following a public notice and comment period. In a recent "Talk Paper," FDA notes that it plans to publish the MRA in the Federal Register "sometime in the near future." Assessments of equivalency also may be open for comment. The process for determining inspection equivalence has not yet been set. The agreement directs both parties to "establish and communicate to each other their draft programs for assessing the equivalence of the respective regulatory systems in terms of quality assurance and consumer protection." Should the equivalence of a regulatory authority be contested, the matter will be referred to a Joint Sectoral Committee, which is "responsible for the effective functioning of the agreement," according to the MRA minutes. The committee, composed of representatives of each party, will be responsible for a range of activities, including amending the transitional arrangements and resolving questions relating to the application of the agreement. Content of inspection reports also remains to be made final. The MRA provides that "as soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed upon inspection format(s)." Details of an alert system also must be completed during the transition period to handle quality defects, recalls, counterfeiting and other problems concerning quality. The definition of Good Manufacturing Practices also must be "revisited," the document states. |