It was published in the Official Gazette no. 10 of 12 January determines Aifa n. 1/2013 with which the powers on clinical trials of medicines already attributed to the Higher Institute of Health are transferred to the Medicines Agency. In practice, phase I clinical trials and clinical trials with products for advanced therapies with the relevant substantial amendments are authorized by AIFA. However, as a note on the! site of the Higher Institute of Health, the new operating procedures for the request for admissibility to the Phase I clinical trial will be published with a Ministerial Decree, pursuant to art. 12, paragraph 9, of the decree-law n. 158/2012. Therefore, at the moment there is a transitional phase in which AIFA makes use of the Istituto Superiore di Sanità for phase I trials, which continues to operate according to the previous procedures. Aifa liaises with the Institute for the purpose of issuing the relative authorisation, while the validation phase of the phase I trial applications remains the responsibility of the ISS. Phase I clinical trials and clinical trials with advanced therapy products with their substantial amendments are authorized by special provision! from Aifa.
January 16, 2013 – DoctorNews33