The Italian Medicines Agency (AIFA) announces the approval of the new Regulation on the functioning and organisation of personnel, a decisive step towards an internal reorganisation aimed at making the system more efficient while at the same time ensuring economic sustainability and patient safety
The reform stems from the need to overcome the fragmentation of office activities and to streamline authorisation processes, with the aim of ensuring faster and more uniform access to innovative therapies At the core of the reorganisation is the systematic adoption of HTA – Health Technology Assessment, a multidisciplinary tool that makes it possible to assess the appropriateness of medicinal product prices in relation to their therapeutic benefits, representing a key element for the governance of pharmaceutical expenditure
The President of AIFA, Robert Nisticò, emphasised that HTA is ‘an essential tool for addressing the increase in costs linked to innovation and to population ageing’, reiterating the Agency’s commitment to ensuring equity of access and the sustainability of the healthcare system.
With this reorganisation, AIFA aims to strengthen its role as guarantor of the quality, safety and efficacy of medicinal products, promoting a governance model capable of combining therapeutic innovation with economic sustainability.
For further details, the official communication is available at: Comunicato_nuovo ordinamento_AIFA_46‑2025
