2012 Ushers in a Closer Relationship between the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
The FDA and the EMA have announced a plan to work together on GMP inspections and information-sharing projects. EMA is responsible for requesting European Economic Area (EEA) inspections in the U.S. and will take the lead on the European Union (EU) side. With the globalization of the manufacture of drugs, authorities from FDA and EMA have experienced an increasing demand for their limited resources. This is because many FDA inspections occur in the EEA, and many EEA authority inspections occur in the U.S. In addition, there is a new trend for drugs manufacturing to be located outside of the U.S and E.U. Both the FDA and the EMA feel that the sharing of resources is extremely important and useful.
This news is good for manufacturers as well. It means that their resources will also be spared from having to go through both FDA and EEA GMP inspections.
The FDA and the EMA plan to execute this new proposed initiative in January of this year. The strategy will take into account a number of considerations before deferring or waiving a GMP inspection on each other’s regions. Specifically, it will affect GMP inspections concerning manufacturing sites in the U.S. and the E.U. involving drugs for both human and veterinary use. The strategy targets sites that have in the past been known to the FDA and the EEA authorities to be GMP compliant. Though pre-approval inspections will stay mostly the same, post-authorization/surveillance inspections will be impacted by this new plan. Both the FDA and the EMA plan to review the strategy after a 3 year period.
For more information on the relationship between the FDA and the EMA and its effect on GMP inspections, click here.