Everybody acknowledges the merits of the European Medicines Evaluation Agency and the progress the European system has permitted in evaluating and approving medicinal products. Nevertheless, the system established in 1995 is ripe for updating and improvement in the light of experience. Some limitations of the procedures suggested by the european Community regulations seem to hamper achievement of the real aims. The scientific community needs to identify the problems and propose and debate solutions with the politicians concerned, so that the european regulatory authority can fulfil its commitment to the defense of public health. The European Commission has made its proposal for improving the system. Here are our first comments.