FDA To Name First Eight EU Member State Inspection Partners Under MRA
FDA is on track to name eight EU member country inspectorates as partners capable of conducting GMP surveillance inspections on behalf of the US by a Nov. 1 deadline. Another four are expected to be named by March 2018. The FDA plans to name all 28 EU member countries as partners by mid-2019.
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FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.
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