[EMA approval procedures and assessment of innovation by AIFA: a cross sectional analysis.]

Innovativeness of medicines is a much debated topic: the Italian Medicines Agency (AIFA) has established criteria according to which new medicines are classified as innovative, while European Medicine Agency (EMA) has established, for medicines of major interest for public health, accelerated assessment procedures to allow faster availability of drugs for patients. The aim of this study is to evaluate the association between the AIFA innovation requirement and the marketing authorization procedures by EMA.

All the medicines for which AIFA has produced an innovation evaluation report were considered, for these same drugs were extracted, from the EMA website, data on: "accelerated assessment", "orphan medicines", "conditional marketing" and authorizations "under exceptional circumstances".

AIFA produced and made available 57 innovativeness evaluation reports for 53 different drugs, expressing a judgment of full innovativeness in 19 cases, conditional innovativeness in 11 cases, non-innovativeness in 25 cases; EMA granted an accelerated assessment to 8 drugs with full innovativeness, 0 with conditional innovativeness and 2 non-innovative drugs respectively.

EMA grants accelerated assessment less often than AIFA's judgment of innovation; these differences may be caused by the different moments of the evaluation, one before and the other after the marketing authorization, or by the similar but different objectives of EMA and AIFA. It is fundamental to recognize innovative medicines to give the patient an extra possibility of treatment in the shortest possible time, at the same time shorten the times of evaluation could represent a risk in terms of safety of use of the treatment. We need a balance, which AIFA is finding with the adoption of the GRADE method to assess the quality of scientific evidence and that the EMA is achieving through the PRIME, a new scheme for "PRIority Medicines".