Agenzia Italiana del Farmaco
Innovative medicinal products
It is up to AIFA and the Scientific Technical Committee to determine the definition of innovativeness, its evaluation and to grant the status of innovative medicinal product which presupposes the evaluation of three basic elements: therapeutic need, added therapeutic value and quality of clinical evidence submitted by the company to support the application for the innovative status of a medicinal product. AIFA has provided that the evaluation of this attribute should take place through a single model for all medicinal products, but allows, if necessary, the use of additional specific indicators.
Criteria for the classification of innovative medicinal products and innovative oncological medicinal products
With Resolution No. 1535/2017, AIFA has identified the criteria for the classification of innovative medicinal products and innovative oncological medicinal products pursuant to Article 1, paragraph 402 of Law No. 232 of 11 December 2016.
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.
Reference offices
Health Budget Monitoring and Regional Relations Office
Francesco Trotta (ad interim)
f.trotta@aifa.gov.it