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INTRODUCTION

: This document aims to provide an overview of the interactions between the Italian Medicines Agency (AIFA) and various stakeholders, placing them in the context of the European and national regulatory framework, with particular reference to Regulation 536/2014 and HTA Regulation 2021/2282.

METHODS

: Through the efforts of a multidisciplinary working group, areas for action and improvement, operational criteria, and tools aimed at optimizing the decision-making process, ensuring greater transparency, and promoting more effective collaboration between the parties involved, have been identified.

RESULTS

: The recommendations included in the document comprise the adoption of thematic round tables and digital platforms for dialogue, the appropriate management of conflicts of interest, and the need for continuous monitoring of interactions. Furthermore, the document emphasizes the importance of a systemic approach that considers the needs of all stakeholders involved, while promoting the centrality of the patient as the main beneficiary of healthcare policies. The concrete application of these measures represents a fundamental step towards a more equitable, transparent, and sustainable healthcare system in the long term. Finally, the paper highlights the opportunity to promote constructive and ongoing dialogue between institutions and stakeholders through innovative technological tools and inclusive participatory processes, in order to consolidate a high-level healthcare governance model.