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Gene Therapy Legislation in Italy

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.

The implementation of Directive 2001/18/EC referred principal on deliberate release of the biotechnology and the Ministry of the Environment is the Competent Authority. The Biosafety Division, Directorate General for Nature Protection of the Italian Ministry for the Environment is involved in Environment Risk Assessment (ERA) of the clinical trials and EMA dossiers (Annex II, Dir 2001/18/CE). The legal framework and competence of this Ministry is explained on their biosafety website http://bch.minambiente.it (English version).

(Last reviewed by the Competent Authority: 11 May 2010)