The Italian Medicines Agency (AIFA) has launched a review of Monitoring Registries that have been active for several years, with the aim of assessing their continued necessity and evaluating potential revisions or closures in light of changes in the regulatory landscape.
The criteria considered by AIFA in its assessment include:
- the duration of monitoring;
- the use of the medicinal product;
- the possible existence of ongoing regulatory procedures;
- other relevant aspects related to the management of the system.
The objective is to streamline the system by simplifying monitoring procedures, reducing the administrative burden associated with completing monitoring forms, and focusing data collection on medicinal products for which monitoring remains necessary.
The review will take into account the available evidence, the use of medicinal products, and developments in the clinical and regulatory landscape.
A step towards a more effective and sustainable system, supporting the monitoring and evaluation of medicinal products.
Any decisions to close Monitoring Registries will be published on AIFA’s institutional website, making the relevant updates available to system users.
Link to the AIFA announcement: https://www.aifa.gov.it/-/aifa-avvia-una-valutazione-dei-registri-di-monitoraggio-di-lunga-durata
