The Italian Medicines Agency (AIFA) has recently published a call for independent research focused on three thematic areas considered of relevant interest: rare diseases, comparative controlled clinical studies and Chimeric Antigen Receptor T-cell (CAR-T cells).
The promotion of independent research represents one of the strategic tasks assigned to AIFA by legislation which goes to reward projects able to enrich clinical and therapeutic knowledge in areas of interest for the National Health Service (NHS) and where commercial support is normally insufficient.
The main purpose of this call, as specified in it, is to “encourage research on issues consistent with the aims and objectives of the National Health Service (NHS), by financing studies of significant interest for the health of citizens, also taking into consideration the potential effects on the regulatory activity of AIFA”.
The amounts allocated to the activity of this Call correspond to a total of six million and five hundred thousand Euros (€ 6,500,000.00).
A special feature of this fund is represented by the mechanism of funding which comes through an innovative policy: all international and national pharmaceutical companies operating in Italy are required to contribute 5% of their yearly expenditure devoted to promotional initiatives to an ad-hoc national fund.
It is also pointed out that the maximum amount that can be funded for each project is one million five hundred thousand euros (1,500,000.00) for interventional studies, five hundred thousand euros (500,000.00) for observational studies and seventy-five thousand euros (75,000.00) for the meta-analysis.
The Project has to be written in English, according to a specific electronic protocol form (dedicated guideline available on the AIFA website) and the deadline for submitting applications to the AIFA system http://aifa.cbim.it/ will be 30 July 2019 at 06.00 PM.
Further information on the call can be found on the AIFA website: http://www.aifa.gov.it/content/bando-aifa-2018-ricerca-indipendente
Regulatory Pharma Net is available to provide additional information and we constantly keep up with regulatory changes in order to inform and support our clients on the consequences of the law modifications.