Agenzia Italiana del Farmaco
Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies - Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies
Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies
The list of medicines that were recognised as innovative in 2025 has been made available only for marketing authorisation holders of medicines with full innovativeness status.
For each product in the list, details are given on the therapeutic indications for which it is authorised and on whether such indications are innovative.
The above information is available, starting today, on AIFA’s Front/End platform in the section entitled "Pharmaceutical expenditure payback for direct purchases in 2025".
This section is accessible by companies using the respective credentials, and comments can be submitted no later than 20thof May at 6pm.
Marketing authorisation holders are therefore asked to check and, if necessary, correct/supplement the information contained in the files in accordance with the instructions laid down in the Annex entitled "Allegato 1 - Istruzioni per la compilazione".
In order to download the files, access the web platform https://www.agenziafarmaco.gov.it/aifarsf/login or alternatively, you can proceed from the AIFA Online services https://servizionline.aifa.gov.it/ and then select the option “Monitoraggio spesa farmaceutica” in the “Consumi e spesa farmaceutica” section.
Published on: 07 May 2026
