Greta Canal -

The Italian Medicines Agency (AIFA) has published the 18th National Report on Clinical Trials of Medicines in Italy, containing data relevant to year 2018. This report provides a periodic update on the qualitative and quantitative trend of clinical research in Italy.

Despite a context of constant contraction of global European Clinical Trial, an increase in the percentage of trials conducted in Italy compared to the rest of Europe (over 20%) occurred in 2018.

Probably the data could reflect a first fallout of the approaching Brexit, with the shifting of the Sponsors to other Member States, but it could also mean an increase in confidence in the Italian system of clinical trials following the publication of Law n. 3/2018 and consequent expectations on a progressive reorganization and simplification at national level with a view to the future application of European Regulation 536/2014.

In 2018 the distribution of clinical trials by therapeutic area confirms the data of the previous years: half of the trials focus on oncology and blood-cancer field.

The upward trend in trials in rare diseases continues significantly, accounting for 31.5% of the total (25.5% in 2017).  Phase I clinical studies on rare diseases are still increasing (33.7%) and the percentage of trials with advanced therapy products in rare diseases is particularly significant (11%, compared to a global increase in trials with equal advanced therapy products of 4.7%). Regarding the pediatric trials, for the first time a reversal trend is occurred, in fact, the percentage of these studies rised to 11.4% of the total compared to 9% last years.

The percentage of no-profit clinical trials has also increased up to 27,3%.

Concerning  Italy participation to the Voluntary Harmonization Procedure (VHP) project for 2018, the number of requests for Italian participation in VHP remained the same as year 2017; however, Italy was one of the main member States to manage VHPs as Reference Member State (third after the United Kingdom and Germany).

The published data show the importance of clinical trials that represents an important part of pharmaceutical research and a fundamental step in the long process to make new therapies accessible to patients. Italy shows that can be competitive in this field.

If you need more details you can find the full AIFA’s report at the following link:

Regulatory Pharma Net is available to provide full support for any query and for the submission of Clinical Trial Applications and the relevant amendments.


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