Registry name: The Italian Medicines Agency (AIFA)
Year established: 2004
Points of interest:
- The Italian Medicines Agency (AIFA) is the main authority for clinical research in the country of Italy
- AIFA manages the National Observatory on Clinical Trials of Medicines (OsSC), which is an operational tool. The OsSC manages phase IV trials that take place in Italy and helps send the trial information to the European EudraCT database.
- Clinical trial registration in Italy must be written in Italian except for the free text core data set, where English is required
- AIFA was the first medicines agency in Europe to promote independent research on drugs
- AIFA is actively present in the European Network of Competent Authorities for clinical trials
- The new version of the OsSC portal opened in early 2019, with the implementation of the new transverbal electronic signature method
- To access the OsSC, sponsors must register with the site and create a username and password
Related transparency research/articles:
- Open-access clinical trial registries: the Italian scenario
- New perspectives and new challenges in clinical trial regulation in Italy
- Clinical trials in Italy
- CenterWatch: Italy clinical trials
TrialAssure® Registry can automate the disclosure of clinical trial results for AIFA. For questions or a free demo, fill out this form.