The world of pharmaceutical care, as we had known and managed it, is being forever revolutionised by new, increasingly personalized treatment options, even designed for individual patients, in some cases at extremely high costs. Regulatory agencies would need to adjust with new procedures and increasingly complex organisations, while continuing to provide the healthcare that patients are accustomed to. A momentous challenge that AIFA anticipated and accepted well in advance, especially at international level, and which has been the subject of in-depth coverage constantly presented to the public through the institutional website and social networks. The significance of the topics covered, the debates taking place worldwide, the comparison between different experiences with the common goal of ensuring the sustainability of innovation and bringing science to the fore of the regulatory system, are the basis on which this book was conceived as a tool for reflection for citizens, healthcare professionals and institutions. •Thoughts from the Italian Medicines Agency (Agenzia Italiana del Farmaco – AIFA) on future challenges in pharmaceutical care and for regulatory agencies •Current scenarios, with references to possible future developments, concerning pharmaceutical care and regulatory agencies •Foreword by Beatrice Lorenzin, Italian Minister of Health