The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the political agreement reached by the European co-legislators, with the aim of a rapid adoption of the new Regulation on Clinical Trials. However, the original objectives of this legislation should be remembered: These were to enhance efficiency in the Clinical Trials Regulation process and, in turn, to boost the EU’s competitiveness as a place to conduct research and make for more efficient patients access to new innovative treatments. EFPIA believes that some of the initial objectives of the legislation have been only partially achieved; therefore the success of this legislation strongly depends on how it will apply in practice.