FDA, EMA Agree to Expanded Sharing of Inspection Information

The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced.

The agreement broadens those reached earlier among the agencies. But before the latest development, the FDA would not share trade secrets without the permission of the affected company, an FDA spokeswoman said. Since 2003, the EU agencies — the European Medicines Agency and the Directorate-General for Health and Food Safety — have provided complete, unredacted reports to the FDA, but the reverse was not the case.

Now, the information will flow freely both ways. In March, the FDA and the EU agencies announced that they would accept the results of each other’s inspections, meaning the FDA would not need to inspect drug manufacturers in the EU and vice versa.