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Focus on Regulation

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.  This is a significant step towards FDA’s stated goal of streamlining global pharmaceutical manufacturing inspections, and in line with the mutual recognition agreement between the FDA and its European counterparts.  According to the announcement, FDA is “on track to meet [its] goal of completing all 28 capability assessments in the EU by July 2019 ”

As we have previously noted, see here, here, and here, this mutual recognition agreement covers the sharing of confidential commercial information, trade secret information, and other non-public information relating to drug inspections and investigations, and frees up FDA resources to focus on higher risk countries, such as India, China, and Asia more broadly.