Joint generic drug inspections initiative announced by FDA and EMA

In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed yesterday (December 19) that they have initiated an initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals.

This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies, the two drug regulatory agencies stated.

Studies submitted for generic drug applications must demonstrate scientifically that a generic drug is “bioequivalent.” These studies help demonstrate that the generic drug performs in the same manner as the brand name drug. The FDA and the regulatory authorities in the European Union inspect facilities that conduct these studies to ensure data submitted to the agencies are reliable. Taking part in this initiative are the EMA and the European Union member states France, Germany, Italy, the Netherlands and the UK.