Posted by Michael Wonder on 26 Nov 2019
Using GRADE methodology to assess innovation of new medicinal products in Italy
25 November 2019 - In April 2017 the Italian Medicine Agency developed new criteria to grant any new medicinal product with an innovative designation.
The aim of this study is to describe this new model and how it works.
A retrospective descriptive analysis was performed on the results of the assessment process of innovativeness of new medicinal products (or therapeutic indications) based on the AIFA's new innovation criteria (therapeutic need, added therapeutic value and quality of clinical evidence through GRADE methodology) carried out between April 2017 and February 2019 and made publicly available on the AIFA website starting from January 2018.
