Category Archive for News Italy
News updates for Italy
AIFA announces funding of CAR-T cell therapy using new reimbursement approach
The Italian Medicines Agency (AIFA) has announced that it will be reimbursing CAR-T cell therapy Kymriah, using a new reimbursement … read more »
Pricing transparency proposals challenged by EFPIA
EFPIA has opposed a price sharing proposal between EU countries suggesting that this could reduce incentives for pharmaceutical companies to … read more »
Updated procedures for accessing the AIFA National Fund (5% Fund)
AIFA has published updates to procedures for clinicians to access the 5% Fund. The 5% Fund is a national fund … read more »
AIFA suspends scientific advice activities
AIFA, the Italian Drug Agency, has posted a notice informing that all activities related to national scientific advice have been … read more »
AIFA has published its first Horizon Scanning report ‘Orizzonte Farmaci. Scenario dei medicinali in arrivo’
The activity of Horizon Scanning has a strategic function for AIFA as it allows the identification and early assessment of … read more »
AIFA update of current rates based on ISTAT index
The AIFA has advised pharmaceutical companies that from 1 April 2019, the tariffs contained in Annex 1 of the Ministerial … read more »
AIFA reminds companies to self-certify for their contributions to the 5% fund
The Italian Medicines Agency (AIFA, Agenzia Italiana del Farmaco) (AIFA) have reminded companies working in Italy to complete the certification forms … read more »
AIFA requirements for the management of clinical trials currently in progress in Italy in case of no-deal Brexit
The AIFA have published requirements on the management of clinical trials ongoing in Italy that Sponsors will have to meet … read more »
Eudamed database will use Italian nomenclature
The European Medical Device Coordination Group (MDCG) have announced that Italy’s ‘National Classification of Medical Devices’ (CND) will replace the … read more »
Changes to the procedure for accessing the AIFA 5% fund
MAP’s partner in Italy, Regulatory Pharma Net, has communicated that the AIFA have made changes to the procedure for accessing the … read more »
