Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Italian Medicines Agency (AIFA). Here is an overview of this registry:

Registry name: The Italian Medicines Agency (AIFA)

Country: Italy

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:

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