Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. One of the main objectives was to mutually recognise the respective GMP inspection systems and reduce the number of foreign inspections.
But has the number of FDA inspections really decreased? A very good source is the FDA Data Dashboard. This detailed overview of FDA activities carried out provides easy-to-use and understandable tables and graphs for comprehensive analysis.
According to the dashboard, quite some “Drug Quality Assurance” inspections were conducted or completed at firms in the EU in 2021 – despite the pandemic and MRA. And pre-approval inspections are not even listed here.
Here is an overview of the number of inspections in EU Member States.
