• Regulatory NewsRegulatory News

    Poland, Slovenia Added to GMP Agreement Between US and EU

    Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals. ...