The EMA and FDA have agreed to recognize each other’s GMP inspections. This Mutual Recognition Agreement goes into effect on November 1, 2017 to allow each other to:
- rely on each other’s GMP inspections;
- waive any requirements for batch testing of products on entry into their territories, after a transition phase;
- share information on inspection outcomes and quality defects.
This means that FDA inspections in the EU or EU inspections in the USA should be only performed in exceptional cases.