The US Food and Drug Administration is finding it increasingly easy to assess the standards of the remaining European inspectorates that are to be included in the mutual recognition agreement (MRA) the US and EU signed last year on recognizing the findings of each other’s manufacturing site inspections. But figuring out how its staff will adapt to using the EU’s certification system for inspections will continue to evolve for the agency.
Since starting its audit of the EU’s supervisory system in 2014, the FDA has learnt “a lot” in terms of...