Attention!
ART.40 of DECREE-LAW no. 23 of 8 April 2020 'Urgent measures on access to credit' repeals ART.17 of the Cura Italia, thus reorganising the urgent provisions on the testing of medicines for the epidemiological emergency by COVID.
What are the differences between the new Article 40 and the repealed old one?
Main innovations
The possibility of submitting and evaluating observational studies and Phase I clinical trials has been added (subject to evaluation by the ISS Commission).
It is clarified that no specific insurance policy is required for non-profit experimental studies
but above all...
It is the National Ethics Committee (Spallanzani) that acquires all the necessary documentation from the promoters together with the protocols of phase I, II, III and IV clinical trials on experimental drugs and observational studies on drugs.
In art. 17 of the Cura Italia the sending of documentation concerning clinical trial protocols was to be done to the PEC AIFA.
Who do we send to in this transitional phase, while we wait for the new simplified procedures?
