The latest step in the increased collaboration between European authorities (represented by the European Medicines Agency - EMA) and the FDA is about to pave the way for a new relationship leading to a better use of inspection resources and some relief to EU and US manufacturers.
The new initiative, starting in January 2012, should enable the authorities in the European Economic Area (EEA) and the US to rely on the results of inspections performed in each other's territories. This should allow at least some inspections to be deferred or waived completely.
As defined in EMA's press release, the goals are to:
However, and, of course, a few considerations need to be taken into account:
After three years, this new initiative and the results will be reviewed.
Source:
- EMA press release
- EMA/INS/GMP/942323/2011
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)