The attention of the Italian Medicines Agency (Aifa) towards the attractiveness of the country as a base to conduct clinical trials has been acknowledged by its general manager, Mario Melazzini during the IX Meeting on Medical Devices. In his intervention, Mr Melazzini presented Aifa’s new “Fast Track” project to establish a rapid procedure for the evaluation of clinical trials. Mr Melazzini also signed the relative Memorandum of Undestandings with the other stakeholders involved in the process.
“Fast track represents an important tool for interactions among different institutional stakeholders involved in the trials’ management”, said Mario Melazzini. The new procedure targets the need to reduce the complexity of the mechanisms leading to the authorisation of a new clinical trial under the Italian regulatory framework and represents Aifa’s concrete answer to the many requests to remove critical steps for the competitiveness and attractiveness of Italy for foreign investments.
According to Mr Melazzini, Aifa worked during the past few months to improve the functionality of the National Observatory for Clinical Trials, with implementation of new tools useful to monitor all the steps of the Fast Track procedure relative to the pharmaceutical products. The set up of the new framework has seen also the collaboration of Italian Regions in order to achieve a uniform view of the approach to be used. “The goal of the project is to assure an harmonic process able to guarantee efficiency, transparency and the time planning needed for evaluation and starting of the trials”, added Aifa’s general manager.