Following the legislative decree n.18 of 17 March 2020, AIFA published an explanatory note on Compassionate Use regarding treatment of COVID-19.
The request to start compassionate use programs for the treatment of COVID-19 must be sent in advance to the Single National Ethics Committee identified by the law (INMI L. Spallanzani) and to AIFA.
The opinion of the Single National Ethics Committee is formulated with an emergency procedure and it is immediately applicable for all the centers and all the patients treated, whereas the nominal therapeutic uses remain subject to the current legislation and therefore remain under responsibility of the local ethics committees.
All the treatments that have received a positive opinion will be published on the institutional website of AIFA, in the appropriate section “Emergency COVID-19”.
Regulatory Pharma Net team is available to fully support companies for any query and for the preparation and submission of the documentation related to compassionate use programs.