AIFA monitoring registries as a strategic tool in the Italian HTA framework: evolution and policy implications

The AIFA (Agenzia Italiana del Farmaco) monitoring registries represent one of the most distinctive regulatory tools within the Italian pharmaceutical governance framework. Initially introduced to support the appropriate use of reimbursed medicines and pharmaceutical expenditure control, they have progressively evolved into an infrastructure linking access to medicines, reimbursement governance, managed entry agreements (MEAs), and real-world data collection. This article examines the evolution and the policy relevance of AIFA monitoring registries within the Italian Health Technology Assessment framework. Firstly, it outlines the legislative and regulatory milestones shaping the system, from the establishment of AIFA in 2003 to the publication of the 2024 guideline, which formally defined the criteria for registry activation. Secondly, it describes the registry types, the criteria guiding their establishment, and the role of MEAs within the monitoring process. Thirdly, it provides an updated overview of the current registry landscape based on AIFA lists, identifying 340 closed registries (March 2026) and 366 active registries (April 2026), with “registri propriamente detti” (comprehensive registries) representing the predominant tool. Among those registries, MEAs were applied in nearly half of cases, with payment by result being the commonest scheme. The article also reviews the use of registry-derived data in peer-reviewed studies across hematology, oncology, cardiovascular diseases, and infectious diseases. Finally, it discusses key challenges, including duplication of information, limited interoperability with healthcare databases, administrative burden and residual discretion in registry activation despite recent transparency reforms. Overall, AIFA monitoring registries emerge as a strategic interface between pharmaceutical regulation, reimbursement governance, and evidence generation.