15 / 16 annual review 13-14 / december-january / p15 ema and fda announces launch collaborative effort builds upon 2009 good clinical practices initiative the european medicines agency (ema) and the united states food and drug admini- stration (fda) has announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted to the ema, the fda and/or to the regulatory authorities in some eu member states in support of marketing- authorisation applications for generic medicines. the joint initiative also introdu- ces a mechanism to conduct joint inspec- tions of facilities where these bioequivalence studies are conducted. successful demonstration of bioequivalence is the basis for the approval of generic medicines. studies submitted in support of generic medicines applications must demonstrate scientifi cally that the generic medicine is “bioequivalent”, or performs in the same manner as the innovator medi- cine. regulatory authorities inspect facilities that conduct these studies to ensure data submitted to the agencies are reliable and of high quality. increased cooperation this initiative will be carried out in the framework of the confi dentiality arrange- ments established between the european commission, the ema, interested eu members states and the fda. the eu member states initially involved in this initiative are france, germany, italy, the netherlands and the united kingdom. additional member states are expected to join the initiative in the future. welcoming the initiative, fergus sweeney, head of the ema’s inspections and human medicines pharmacovigilance division, said: - the progress of this initiative is testi- mony to increased cooperation and the hard teamwork of the inspection staff of all our agencies, helping us to better leverage our respective inspection resources. globalisation of clinical trials means that 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