US FDA-MMA Mutual Recognition Agreement

Published: 03 Nov 2017

1st November 2017 is an important milestone for the Malta Medicines Authority as the US Food and Drug Administration (US FDA) confirmed that Malta’s inspectorate has the capability, capacity and procedures in place to supervise manufacturers of medicines at an equivalent level to the US.

The news has been described by the European Medicines Agency (EMA) as unprecedented as the US FDA has never before recognised another country’s inspectorate. The Malta Medicines Authority is one of the first eight Inspectorates to be recognised by the US FDA and it is a major milestone towards closer cooperation to improve the use of available resources to safeguard quality and safety of medicines.

Read more here: ENG or MLT version.

Latest News Updates

28 Sep 2021

Organisation Management Service (OMS) integration with EudraGMDP - Human and Veterinary industry preparedness