Italian Medicines Agency

The Agency makes available the evaluation reports for the recognition of the innovative status, for therapeutic indication, in compliance with the provisions of AIFA Resolution No. 1535/2017.

AIFA publishes the updated list of the medicinal products which, in the opinion of the Scientific Technical Committee, fulfil the requirement of therapeutic innovativeness/important and/or potential therapeutic innovativeness/conditional, pursuant to Article 10, paragraph 2 of Law No. 189/2012, as defined by Article 1, paragraph 1 of the State Regions Agreement of 18 November 2010 (Rep.Atti No. 197/CSR).

AIFA publishes the lists of innovative medicinal products that can access the Funds provided for in the 2017 Budget Law: the first is the "Fund for the contribution to the reimbursement to the Regions for the purchase of innovative non-oncological medicines", the second is the "Fund for the contribution to the reimbursement to the Regions for the purchase of innovative oncological medicines" (the reference to the inclusion in the list is also published in a Resolution in the Official Journal for each individual specialty).

The Agency publishes the lists of innovative medicinal products subject to monitoring in accordance with the 2017 Budget Law. There are different tables for oncological and non-oncological medicinal products and they are constantly updated following the authorisations published in the Official Journal.