In brief

On 18 April 2024, the State and Regions’ Conference approved the Agreement proposed by the Ministry of Health for the implementation of an active pharmacovigilance program.

Key takeaways

The Agreement will be implemented by signing conventions between the Italian Medicine Agency (AIFA) and single Regions, through which the Pharmacovigilance Funds, relating to the years 2018, 2019, 2020, 2021 and 2022, will be disbursed, for an overall total of 58.5 million euros.

The purpose of these Funds is to ensure the continuity of regional pharmacovigilance activities homogeneously throughout the country and with the contribution of each Region. To this end, the Agreement provides for the launch of initiatives aimed at improving knowledge about medicines from a benefit-risk perspective after they have been marketed. Such initiatives include the activities conducted by regional pharmacovigilance centers, the assessment of the use of medicines and of the effectiveness of the risk-minimizing regulatory actions, and the independent scientific information to healthcare professionals and citizens.

A portion equal to 6% of the available Funds will be managed by the AIFA for the costs of coordinating and monitoring activities, including those of organizing and directing the regional pharmacovigilance centers, evaluating the activities proposed by the individual Regions to access the Pharmacovigilance Funds, signing the necessary agreements, providing the funds and monitoring the activities and the related control of compliance with the pharmacovigilance regulations and the specific operating procedures.