Valentina Ciurlia -

As of March 6th, 2022, with the entry into force of the Ministerial Decree of November 30th, 2021, concerning the measures intended to facilitate and support the conduct of no-profit clinical trials of medicines and observational studies and the transfer of the relevant data and results for registration purposes, important changes have been introduced in Italy for the management of these kind studies.

One of the most important innovation concerns the transfer of data and results of non-profit trials for registration purposes; in particular:

  • The transfer of data and results of no-profit trials for registration purposes can be performed both during the trial and after its completion
  • When data and/or results are transferred for registration purpose in Italy or abroad:
    • Sponsor has to bear and reimburse all direct and indirect expenses concerning the trial and pay the relevant fees due to Italian Authority and Ethic Committee;
    • an estimate of the value of the asset in question in view of its expected commercial exploitation has to be performed by a patent advisor registered in the Register of Industrial Property Consultants
    • The transfer of data from no-profit trials must be regulated by means of a specific agreement between the sponsor and transferee.
  • for companies who intend to start this kind of trials, financial benefit is expected.

Another important news concerns the observational studies, which will have to be entered by the Sponsor into a national register. Specific guidelines will be published by the Italian Competent Authority in the next weeks.

Regulatory Pharma Net is available to provide your company with any further updates on this topic and is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments.


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