The Italian Medicines Agency has published the Guideline for the classification and conduct of observational studies on medicines in line with the provisions of the Ministerial Decree of 30 November 2021 - art. 6 paragraph 3, as part of the Italian legislation to comply with the requirements of Regulation (EU) no. 536/2014, which also includes specific provisions on observational studies, both profit and non-profit.

Pharmacological observational studies are particularly important for the evaluation of the safety profile in normal conditions of use and on large numbers of subjects, for in-depth analysis of the efficacy in real life conditions, on the use of medicines, for the verification of the appropriateness of prescription and for pharmaco-economic evaluations.

The Guideline applies to all categories of observational pharmacological clinical studies and responds to the objective of providing clear and precise indications on their correct classification and on the operational aspects to be taken into particular consideration in the regulatory activities of conduct and evaluation by the Ethics Committees.

The new Guideline updates and replaces the previous one, issued with AIFA directorial decision of 20 March 2008 and which no longer adequately reflected the needs of a sector that has undergone significant technical-scientific evolution in recent years. In drafting the new Guideline, AIFA paid particular attention to these renewal needs, which also involve the regulatory framework by incorporating the innovations arising from Regulation (EU) no. 536/2014, the national adaptation legislation, the recommendations of the interested stakeholders and the evolution of the scientific context.

In consideration of the impact of the document, before defining the final version, AIFA started a consultation phase with the Ethics Committees, to reflect their concrete experiences in the evaluation of these studies. The consultation was launched with an initial collegial discussion during the event “Meeting with the Territorial and National Ethics Committees” on 22 November 2023 and then continued with a survey on some specific points for which the need for an in-depth discussion had emerged. The analysis of the responses of the Ethics Committees to the ten questions and the numerous comments received was carried out by AIFA and also saw a phase of collaboration with the Working Group on Clinical Research with Medicines and Medical Devices for Human Use established by Minister of Health Schillaci, in which all the stakeholders involved in this type of study are represented, in order to include all points of view as broadly as possible.

The Observational Studies Registry (RSO) remains the tool for collecting information relating to observational studies carried out in Italy and useful for carrying out descriptive analyses and preparing periodic reports. The contents and operating methods of the registry in accordance with the new Guideline will be communicated to operators via the AIFA institutional portal.