International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.

A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However, the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all member states’ authorities for human pharmaceuticals, which is expected to be completed no later than 15 July 2019.

« Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track, » the European Commission said Thursday.

An expansion of the agreement to cover veterinary medicines will be assessed by 15 July 2019 and vaccines for human use and plasma-derived medicines by 15 July 2022…