13/14 March 2024
Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has completely entered into force. One of the main objectives was to mutually accept the respective GMP inspection systems and to reduce the number of foreign inspections.
But has the number of FDA inspections really decreased? At least for 2019 we have some numbers now. FDA's Office of Pharmaceutical Quality has published its 2019 Annual Report "One Quality Voice". Here it is stated that in 2019, "the FDA was able to reduce 25% of routine surveillance inspections in the European Union because of reliance on trusted partner reports through this agreement."
This is a first step towards a reduction of FDA inspections in the EU. As said above the agreement started in July and FDA mainly accepted EU inspection reports issued after that date.
We will have to see what the future will bring. On their MRA website updated on 08 May 2020, the FDA writes that "FDA will continue to perform some inspections in EU countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in EU countries with a capable inspectorate." So the FDA inspections won't stop completely and it will be interesting to see the new numbers in next year's report.