Skip to main content

Observatories and databases

Observatories and databases are essential tools through which the Agency controls and analyses drug utilization at national, regional and local level, it monitors clinical trials approved by Local Ethics Committees and integrates the information obtained from the national pharmacovigilance network.

  • The Medicines Utilization Monitoring Centre (OsMED): it monitors drug prescriptions financed by the National Health Service and provides with monthly reports to the Regional Authorities according to pre-defined indicators on drug consumption and expenditure. It publishes the annual of the Drug Utilisation Monitoring Centrereport (in Italian).
  • The National Monitoring Centre for Clinical Trials (OsSC)ensures the monitoring of all clinical trials conducted in Italy and approved by the Competent Authority and  Local Ethics Committees, moreover – starting from October the 1st 2014 – it manages the e-submission of CTAs and related substantial amendments for regulatory and ethics review, and the follow-up of administrative information (status/end of trial, summary of results); this observatory, is accessible to the Competent  Authority, the Ethics Committees, the Regional Authorities and the Applicants. It publishes the annual report on clinical research in Italy, a brief summary of which is also available in English (Bulletin Clinical Trials of Drugs in Italy).
  • The National Monitoring Centre for Pharmacovigilance: it collects, through a national network, all the adverse drug reactions reports and supervises the risk-benefit profile of drugs; it is integrated with the European database EUDRAVigilance. It publishes an annual report on Pharmacovigilance in Italy.
Data aggiornamento: November 2014
Skip to main content Skip to the top of the page