The conversion into Law of the Decree Law no. 158 of 13 September 2012 AIFA will be assigned with the authority for clinical trials previously assigned to ISS by the Legislative Decree 211/2003.
In the meantime, in order to assure the correct carrying out of the activities concerned by these regulatory changes, the Italian Medicines Agency and the National Institute of Health (Istituto Superiore di Sanità - ISS) announced that the ISS will continue to perform the same activities, according to the usual operating modes, electronically informing AIFA about the new requests of authorization for phase I clinical trials, submitted to ISS by the Sponsors.
