FDA, European Medicines Agency Launch Project to Share Bioequivalence Study Data

The Food and Drug Administration and the European Medicines Agency (EMA) Dec. 18 announced a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals.

This collaboration, which began Jan. 2, provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both the FDA and the EMA, the agencies said.

Studies submitted for generic drug applications must demonstrate scientifically that a generic is “bioequivalent,” the agencies said. These studies help demonstrate that the generic drug performs in the same manner as the brand-name drug.

The FDA and the regulatory ...