FDA to accept GMP inspections from two more EU countries

The US Food and Drug Administration (FDA) has accepted that regulators from two further European Union (EU) countries are capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to the USA.

Bulgaria and Cyprus have this week been included into the mutual recognition agreement between the EU and the USA.

The agreement recognizes inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 24 EU member states whose inspection results can replace their own inspections.