11 August 2020
In our news All Things come to Those who wait ... Germany approved by MRA EU-USA you could read that one EU Member State (Slovakia) was still missing for the complete implementation of the MRA agreement between the EU and the USA. The goal was for all EU Member States to be recognised by 15 July 2019.
Now, this goal has been achieved. With the acceptance of Slovakia on 11 July 2019, all EU member states are now recognised by the USA. The FDA was already recognized by the EU in 2017. Under the heading "A New World for Pharmaceutical Inspections", the FDA explains what is expected from the MRA. It will be interesting to see whether, as hoped, FDA routine inspections in Europe will be reduced. And if so, to what extent the reductions will be achieved. Further information can be found in a Question & Answer (Q&A) document from the FDA. It is worth noting, for example, that the answer to question 15 also mentions pre-approval inspections as part of the MRA agreement. However, the FDA assumes an additional coordination and assessment for these inspections.