Gene Therapy Legislation in Italy

The applications to seek the authorization under clinical trial and GMO frameworks have to be submitted to Italian Medicines Agency (AIFA) and Ministry of Health (Competent Authority for the contained use). In addition, if the assessment of a genetically modified microorganism (GMM) contained use shows that the medicinal product contains a GMO that can replicate, transmit and disseminate into the environment, an authorization under Part B of Directive 2001/18 should also be obtained from the...