Francesca Spera -

The Italian Medicines Agency (AIFA) has published an update concerning the documentation for the submission of Phase I, II, III and IV clinical trial applications and related substantial amendments.

For authorization requests submitted through the OsSC platform, it will no longer be necessary to send to AIFA the package containing the paper documentation and the CD-ROM(s) provided that certain requirements are met.

However, the submission in transitory paper mode is permitted in the cases illustrated in the AIFA press release dated December 20th, 2018 (“Procedures to be followed in the event of OsSC malfunction“).

In addition, new models of transmission letters have been published: further declarations have been inserted regarding the possible use of medical devices, artificial intelligence systems or Machine Learning.

For more details you can find the full notice at the following link:

RPN constantly monitors the AIFA website in order to stay up to date on clinical trials and observational studies and it is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments as well as for the notifications of observational studies.


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