The competent authority for conducting clinical gene therapy trials in Italy is the Agenzia Italiana del Farmaco (AIFA), which is part of the Health Ministry. In order to receive an authorisation for a clinical trial an applicant needs to pass a local Ethics Committee (reviewing ethical and scientific aspects) and an administrative review. The administrative authorisation is issued by the National Institute of Health (for Phase I studies), the AIFA (for gene therapy) and the General Director of local Health Unit (for all the other Clinical Trials). An AIFA review and authorisation is a requirement before the clinical gene therapy trial can start. The Istituto Superiore di Sanità (ISS) is responsible for the scientific evaluation of
requests for gene and cell therapy.
