For years the FDA and the European Medicines Agency (EMA) have been edging closer to the day when they will recognize the plant inspections each does in their own areas to save on tightening resources in an ever-expanding industry. Now that day has arrived.
Both regulators reported that they have agreed to recognize inspections that each performs of human drug manufacturing facilities conducted in their respective territories on both sides of the Atlantic. That means inspectors from the various oversight agencies in the European Union will no longer need to inspect sites in the U.S., and the FDA likewise will rely on those agencies for inspections in their own countries, unless there are "exceptional circumstances" that would lead one or the other to insist on their own inspection.
The new arrangement is set to begin Nov. 1, but whether the new approach will survive under a newly appointed commissioner of the FDA and the administration’s “America first” approach is to be seen. An FDA spokesperson said that “the FDA/HHS transition team was briefed on this agreement.”
“Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk,” the FDA said in announcing the arrangement.
The EU said the agreement is based on “robust evidence on both sides of the Atlantic” that the EU and the U.S. have comparable regulatory approaches to inspections.
Since May 2014, the FDA said it and the EU have been evaluating how each does their inspections.