FDA and the EU have made significant progress down the long and winding road of formalizing an agreement to rely on each other’s drug GMP inspections.
An intensive mutual evaluation process has been underway over the past two years – including direct observance of each other’s inspection processes – that is providing the foundation and confidence needed to move to the sign-off stage.
In a keynote presentation that commenced the ISPE/FDA/PQRI Quality Manufacturing Conference in Bethesda, Maryland in June, FDA Associate Commissioner for Global Regulatory Policy Dara Corrigan provided an informed review of the heightened motivation and concerted effort it has taken to pave the way for an inspection reliance agreement between the US and EU.
Corrigan returned to FDA headquarters in the later part of 2015 after a two-plus year assignment as the second director of FDA’s European Office in Brussels, Belgium. Finding a way to move forward on an inspection MRA was a first-order priority during her tenure in Brussels, as an important component in FDA’s risk-based strategy to address its global regulatory challenges.