September 2024
In brief
On 21 August 2024, the Italian Medicine Agency issued the Guidelines on the matter of Regulatory Simplification and Decentralization for the Purpose of Conducting Clinical Trials of Medicinal Products in Accordance with Regulation (EU) No. 536/2014.
Key takeaways
These Guidelines, which focus on organizational issues specific to the Italian context, address a number of aspects related to clinical trials, including the use of service providers, reimbursement of expenses and indemnities for clinical trial subjects, home delivery of the investigational drugs, allocation of costs related to investigational drugs for marketing authorization purposes, and clinical trials conducted in out-of-hospital settings.
In relation to these areas, which have already been addressed by several recommendation papers developed within the European network, the Italian Medicine Agency deemed it appropriate to regulate in detail those organizational aspects for which there was a lack of clear references at the national level, with the aim of ensuring that the provisions contained or not expressly prohibited in EU standards and guidelines are correctly applied in Italy.
