The main objective of this law is to achieve greater international competitiveness in the field of clinical trials through the following provisions: Evaluations of clinical trials by ethics committees/substantial modifications Among these alternative measures, sponsors/CROs may also consider carrying out certain health activities, such as non-self-administered therapies (for example. B infusions) and other clinical procedures such as documenting adverse events or vital signs directly in the patient. Article 1 of Decree-Law 211/2003 prohibits the offer, granting or requirement of financial incentives or other benefits for clinical trial participants, with the exception of allowances granted to healthy volunteers. The sponsor is a public body, quotas can only be granted within the budget available to it. Decree-Law 211/2003 requires the promoter to provide insurance to compensate clinical trial participants for all damage resulting from the experimental activity. The insurance policy must cover the responsibility of the examiner and sponsor. The first step in the implementation of the Legge Lorenzin was the creation by the Italian Medicines Agency (AIFA) of the National Centre for the Coordination of Territorial Ethics Committees. Because the legislation allows the government to adopt one or more framework decrees on the minimum content of clinical trial agreements (“ATCs”) covering certain aspects of clinical trial conduct, AIFA has launched a public consultation on the two CTA model projects (one model for drugs and one for clinical trials on medical devices) to gather advice and proposals for improvement. The CTA consultation ended on May 10, 2019 and AIFA reviews all proposals received.
All legal aspects related to preclinical and clinical requirements in… No no. However, if part of the drug development (including clinical trials) has been carried out in Italy, the holder of the marketing authorization may be strengthened when negotiating the price of the product with AIFA (for products financed by reimbursement).