US-EU Mutual Reliance On Drug Facility Inspections Nears Reality
This article was originally published in The Pink Sheet Daily
FDA expects to complete work this year on decision model to determine whether an EU member state's inspectorate is capable of conducting inspections that meet US requirements.
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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.
FDA still does over 40% of its inspections in Europe even as it acknowledges it must spend the money elsewhere.
Agency restructures staff as it prepares for new U.S.-EU mutual reliance activities to enhance pharmaceutical quality but offers few details on upcoming plans.