The Italian Medicines Agency makes available the Guideline on regulatory simplification and elements of decentralisation for the purpose of conducting clinical trials of medicines in accordance with Regulation (EU) No. 536/2014 applicable to clinical trials of medicines and focused exclusively on organisational aspects specific to the Italian context.

This Guideline addresses a series of aspects relating to clinical trials that are of an organisational nature and that are part of areas of profound innovation, including aspects of decentralisation of clinical trials, also taking into account the imminent update of the ICH E6 Guidelines. These areas are already the subject of several "recommendation papers" developed within the European network, to whose drafting AIFA has actively contributed, making them fully applicable also in the Italian context. Also in light of this activity, AIFA deemed it appropriate to regulate in detail those organisational aspects for which there were no clear references at national level, with the aim of ensuring that the provisions contained or not expressly prohibited in European standards and guidelines can be correctly applied in Italy.

The Guideline deals with issues such as the use of service providers, reimbursement of expenses and compensation for loss of earnings for participants in clinical trials, home delivery of the experimental medicine, the attribution of costs relating to experimental and auxiliary medicines and finally clinical trials carried out in extra-hospital settings.

The Guideline was drafted also taking into account the contributions on the matter by the Working Group on Clinical Research with Medicines and Medical Devices for Human Use, established by Minister of Health Schillaci.