In this issue of Recenti Progressi in Medicina you will find the recommendations of a Focus group that analyzed the early access drug programs and managed entry agreements in Italy. In general, the extreme attention to the exclusive reduction of the evaluation times has led over time to take advantage of regulations born with other reasons. In particular, the law 648/96 should rather respond to unmet therapeutic needs while the AIFA 5% fund to individual and urgent request of drugs which are still not available in our country. In addition to a specific procedure on early access, there are missing steps that allow to allow a governance of these exceptional paths throughout monitoring protocols with methodologies and time scheduled well defined. In this context, the research supported by AIFA might be very helpful for the decision makers in order to overcome uncertainties during the marketing authorizations.