The European Medicines Agency and the US Food and Drug Administration have unveiled an initiative to share information on bioequivalence studies for generics and conduct joint inspections of facilities where these trials take place.

As well as the two regulators, the plan will also see France, Germany, Italy, the Netherlands and the UK take part, while additional European member states are expected to join the initiative. It includes an 18-month pilot phase and builds on the 2009 EMA-FDA Good Clinical Practice initiative which was designed to ensure that trials are conducted ethically and that the data generated are reliable.

The scheme will involve sharing information on negative reviews and covers sites all over the world. The EMA and FDA add that they will provide training opportunities to improve bioequivalence inspections.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said this continued collaboration "enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalisation in drug development". She added that "by streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs".
Ms Woodcock's comments were echoed by Fergus Sweeney, head of the EMA’s inspections and human medicines pharmacovigilance division. Noting the "increased cooperation and the hard teamwork of the inspection staff of all our agencies", he said that given the global nature of the business, "we all rely on each other to assure the quality of bioequivalence clinical trials, and data from these, on which the approval of generic medicines, and therefore the health of EU and American patients, rely".