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  • Report Clinical Trials of Drugs in Italy 2014

    Deep regulatory changes have occurred in 2013, with a subsequent strong impact on the clinical research main actors’ daily work (the transfer of the role of competent Authority to AIFA in accordance with Law 189/2012, the “reorganization” of the Ethics Committees according to Ministerial Decree of February 8, 2013): as a consequence, the topic of the attractiveness of Italy as an area in which to invest in clinical trials has been one of the most discussed and salient.
    The year 2013 has also been an intense year of work for Member States participating in the Working Group on Clinical Trials Regulation at the EU Council in Brussels, whose activity has led to the approval of the final text of the Regulation in December 2013, with the subsequent adoption by the Parliament on April 16, 2014 (CT Regulation no. 536/2014).


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