European Medicines Agency (EMA) Mutual Recognition Agreement (MRA)

Posted on

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.

Read more here.