Public Health Europe - European Commission - EU

The recognition today by the U.S. Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, marks the full implementation of the EU-U.S. Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for human medicines in their respective territories.

The editorial articles for this issue were prepared by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMES (DG GROW).

In a joint letter published today, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reminded all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database.

The US Food and Drug Administration (FDA) confirmed the capability of Germany to carry out good manufacturing practice (GMP) inspections at a level equivalent to that of the US. There are now a total of 27 Member States whose inspection results the FDA can rely on to replace their own inspections.